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J O U R N A L O F T H E AM E R I C A N C O L L E G E O F C A R D I O L O G Y V O L . 6 9 , N O . 9 , 2 0 1 7

ª 2 0 1 7 T H E A U T HO R S . P U B L I S H E D B Y E L S E V I E R O N B E H A L F O F T H E A M E R I C A N

C O L L E G E O F C A R D I O L O G Y F OU N D A T I O N . T H I S I S A N O P E N A C C E S S A R T I C L E U N D E R

T H E C C B Y - N C - N D L I C E N S E ( h t t p : / / c r e a t i v e c o mm o n s . o r g / l i c e n s e s / b y - n c - n d / 4 . 0 / ) .

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SPECIAL FOCUS ISSUE: CARDIOVASCULAR HEALTH PROMOTION

ORIGINAL INVESTIGATIONS

Effect of Current DietaryRecommendations on Weight Loss andCardiovascular Risk Factors

David J.A. Jenkins, MD,a,b,c,d Beatrice A. Boucher, MHSC,a,e Fredrick D. Ashbury, PHD,f,g,h,i Margaret Sloan, BA,e

Patrick Brown, PHD,e,f Ahmed El-Sohemy, PHD,a Anthony J. Hanley, PHD,a Walter Willett, MD,j

Melanie Paquette, MSC,a,c Russell J. de Souza, SD,k Christopher Ireland, BSC,a,c Natalie Kwan, MSC,a,c

Amy Jenkins, MSC,c,l Sathish C. Pichika, MSC,a,c Nancy Kreiger, PHDa,e,f

ABSTRACT

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BACKGROUND Dietary recommendations emphasize increased consumption of fruit, vegetables, and whole grain

cereals for prevention of chronic disease.

OBJECTIVES This study assessed the effect of dietary advice and/or food provision on body weight and cardiovascular

disease risk factors.

METHODS Healthy overweight men (n¼ 209) and women (n¼ 710), mean age 44.7 years, body mass index [BMI]

32.4 kg/m2, were randomized between November 2005 and August 2009 to receive Health Canada’s food guide (control,

n ¼ 486) or 1 of 3 interventions: dietary advice consistent with both Dietary Approaches to Stop Hypertension (DASH) and

dietary portfolio principles (n¼ 145); weekly food provision reflecting this advice (n¼ 148); or food delivery plus advice

(n¼ 140). Interventions lasted 6 months with 12-month follow-up. Semiquantitative food frequency questionnaires and

fasting blood, anthropometric and blood pressure measurements were obtained at baseline, 6 months, and 18 months.

RESULTS Participant retention at 6 and 18 months was 91% and 81%, respectively, after food provision compared to

67% and 57% when no food was provided (p < 0.0001). Test and control treatments showed small reductions in

body weight (�0.8 to �1.2 kg), waist circumference (�1.1 to �1.9 cm), and mean arterial pressure (0.0 to �1.1 mm Hg) at

6 months and Framingham coronary heart disease risk score at 18 months (�0.19 to �0.42%), which were significant

overall. Outcomes did not differ among test and control groups.

CONCLUSIONS Provision of foods increased retention but only modestly increased intake of recommended foods.

Current dietary recommendations showed small overall benefits in coronary heart disease risk factors. Additional dietary

strategies to maximize these benefits are required. (Fruits, Vegetables, and Whole Grains: A Community-based

Intervention; NCT00516620) (J Am Coll Cardiol 2017;69:1103–12) © 2017 The Authors. Published by Elsevier on behalf

of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://

creativecommons.org/licenses/by-nc-nd/4.0/).

m the aDepartment of Nutritional Sciences, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; bLi Ka Shing

owledge Institute, St. Michael’s Hospital, Toronto, Ontario, Canada; cRisk Factor Modification Centre, St. Michael’s Hospital,

ronto, Ontario, Canada; dDivision of Endocrinology and Metabolism, St. Michael’s Hospital, Toronto, Ontario, Canada; ePre-

ntion and Cancer Control, Cancer Care Ontario, Toronto, Ontario, Canada; fDalla Lana School of Public Health, University of

ronto, Toronto, Ontario, Canada; gInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto,

tario, Canada; hDivision of Preventive Oncology, University of Calgary, Calgary, Alberta, Canada; iDepartment of Psychology,

culty of Social Sciences, University of Wollongong, Wollongong, New South Wales, Australia; jNutrition Department, Harvard

ool of Public Health, Harvard University, Boston, Massachusetts; kDepartment of Health Research Methods, Evidence, and

pact, McMaster University, Ontario, Canada; and the lDepartment of Food Science, University of Guelph, Guelph, Ontario, Canada.

ABBR EV I A T I ON S

AND ACRONYMS

BMI = body mass index

CHD = coronary heart disease

CVD = cardiovascular disease

HDL = high-density lipoprotein

LDL = low-density lipopro

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Jenkins et al. J A C C V O L . 6 9 , N O . 9 , 2 0 1 7

Effect of Dietary Recommendations on Risk Factors M A R C H 7 , 2 0 1 7 : 1 1 0 3 – 1 2

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D ata from major cohort studies sug-gest that 82% of cardiovasculardisease and 91% of diabetes risk

may be prevented by changes in diet andlifestyle (1,2). To address the growing burdenof chronic disease, dietary guidelines for thegeneral public, including the Dietary Refer-ence Intakes for the United States and Can-

ada, focus on chronic disease reduction in additionto simple nutritional adequacy. The most recent sci-entific recommendations of the U.S. Dietary Guide-lines Advisory committee now advocate 3 dietarypatterns to prevent chronic disease: the healthyAmerican diet, the Mediterranean diet, and for the

tein

SEE PAGE 1113

first time, a vegetarian diet (3). All of these dietarypatterns incorporate traditional advice to eat morefruit, vegetables, and whole grain cereals, plus morerecent advice to eat more cholesterol-lowering “func-tional” foods such as oats, barley, nuts, and plant pro-tein foods (e.g., soy and other legumes). This dietaryapproach fits with the recent report of the workshopconvened by the World Heart Federation (4). Thera-peutic diets such as the Dietary Approaches to StopHypertension (DASH) recommended in the AHA/ACCguidelines (5) and the dietary portfolio recommended

ch was supported by Institute of Nutrition, Metabolism, Diabetes

. Ltd. Dr. Jenkins was funded by the government of Canada thr

e food basket were contributed by Loblaw Cos. Ltd., Alberta Barle

th’s Own Food Co. Inc., International Nut Council, Kellogg Co., M

nd So Soyaþ Inc. Dr. Jenkins has received research grants from Sa

Program through the Pulse Research Network, Advanced Foods

ond Board of CA, Agriculture and Agri-food Canada, Pulse Ca

amble Technical Centre Ltd., Bayer Consumer Care, Pepsi/Quake

orth America, Coca-Cola Co. (investigator-initiated, unrestricted

al Tree Nut Council Nutrition Research and Education Founda

nola Council of Canada, Canadian Institutes of Health Researc

und; and has served on the speaker’s panel and scientific advisory

d Board of California, Canadian Agriculture Policy Institute, Lobla

skatchewan Pulse Growers, Sanitarium Co., Orafti, American Pean

nd Education Foundation, Peanut Institute, Herbalife Internatio

Health, Metagenics, Bayer Consumer Care, Unilever Canada an

bbott Laboratories, Dean Foods, California Strawberry Commi

-Bred International, DuPont Nutrition and Health, Spherix Consu

twork, Canola and Flax Councils of Canada, Nutritional Fundame

an Agri-Food Policy Institute, Pulse Canada, Saskatchewan Pulse

oundation of Italy, Nutra-Source Diagnostics, McDougall Progra

pital), Canadian College of Naturopathic Medicine, Hospital for S

utrition, Arizona State University, Paolo Sorbini Foundation and

d honoraria from U.S. Department of Agriculture; and has received

al Nut and Dried Fruit Council; and has received funding and tra

olism. Dr. de Souza has received personal fees from World H

ealth Canada; and grants from Dietitians of Canada and Canadia

f Vineland Research and Innovation Centre, a not-for-profit org

lationships relevant to the contents of this paper to disclose.

received August 27, 2016; revised manuscript received Septemb

in the Canadian Cardiovascular Society guidelines (6)to lower cholesterol also emphasize these principlesand consistently result in large reductions in bloodpressure and lipids when taken under metabolicallycontrolled conditions (7–9). Yet despite efforts toencourage the general public to increase plant foodconsumption, the response has been slow (10).

We determined whether we could increase adher-ence to the DASH-type and dietary portfolio eatingpatterns and improve health outcomes by providingboth advice and food to healthy overweightindividuals.

METHODS

PARTICIPANTS. Participants were residents of thecity of Toronto, 18 years or older, English speaking, andhad body mass index (BMI) >25 kg/m2. Individuals orfamilies were recruited if at least 1 family member hadBMI >25 kg/m2, and blood pressure and thyroid medi-cations (thyroxin) dosages, if taken, were stable for atleast 1 month prior to starting the study. Exclusioncriteria included pregnancy or breastfeeding; activelyfollowing a special diet or weight-loss program; majorsurgery or a cardiovascular event in the previous 6months; diabetes, liver disease, renal failure, cancer(except nonmelanoma skin cancer), inflammatorybowel disease or major chronic inflammatory diseases;

of the Canadian Institute for Health Research, and

ough the Canada Research Chair Endowment. Food

y Commission, Almond Board of CA, Barilla, ConAgra

ars Canada, Pepsi-QTG Canada, Puresource Natural

skatchewan Pulse Growers, Agricultural Bioproducts

and Material Network, Loblaw Cos. Ltd., Unilever,

nada, Kellogg’s Co., Canada, Quaker Oats, Canada,

r, International Nut & Dried Fruit, Soy Foods Asso-

grant), Solae, Haine Celestial, Sanitarium Co., Orafti,

tion, Peanut Institute, Canola and Flax Councils of

h, Canada Foundation for Innovation and Ontario

board and has received travel support and honoraria

w Cos. Ltd., Griffin Hospital, Coca-Cola Co., Epicure,

ut Council, International Tree Nut Council Nutrition

nal, Pacific Health Laboratories, Nutritional Funda-

d Netherlands, Solae, Kellogg, Quaker Oats, Griffin

ssion, Haine Celestial, PepsiCo, Alpro Foundation,

lting and WhiteWave Foods, Advanced Foods and

ntals for Health, Agri-Culture and Agri-Food Canada,

Growers, Soy Foods Association of North America,

m, Toronto Knowledge Translation Group (St. Mi-

ick Children, Canadian Nutrition Society, American

Institute of Nutrition, Metabolism, and Diabetes; and

the 2013 Award for Excellence in Research from the

vel support from Canadian Society of Endocrinology

ealth Organization, Canadian Institutes for Health

n Institutes for Health Research. Amy Jenkins is an

anization. All other authors have reported that they

er 17, 2016, accepted October 18, 2016.

J A C C V O L . 6 9 , N O . 9 , 2 0 1 7 Jenkins et al.M A R C H 7 , 2 0 1 7 : 1 1 0 3 – 1 2 Effect of Dietary Recommendations on Risk Factors

1105

acute or chronic infections, irritable bowel syndrome;peanut or nut allergy; or a blood pressure >145/95mm Hg on more than one occasion.

PROTOCOL. Eligible participants recruited by adver-tisements between October 2005 and July 2009 weresent questionnaires including a semiquantitativefood frequency questionnaire (11). Completed ques-tionnaires, fasting blood, anthropometric, and bloodpressure measurements were obtained at baselineand at subsequent clinic attendances at 6 and 18months at St. Michael’s Hospital, a University ofToronto Teaching Hospital. Research Ethics boards ofthe University of Toronto and St. Michael’s Hospitalapproved the protocol. All participants providedsigned consent. The trial was registered withClinicalTrials.gov (NCT00516620).

DIETARY INTERVENTIONS. All participants receiveda copy of Health Canada’s Food Guide. No furtheradvice was given to the control group. The firsttreatment group received additional dietary adviceweekly for the first month and monthly for thefollowing 5 months as 20- to 30-min telephone in-terviews with individual participants or the families’primary shopper or cook. The advice addressed ben-efits, strategies for change, and barriers to change foreach participating family member. Participants wereencouraged to increase intake of fruit, vegetables,whole grain cereals, to reduce meat and sweets, andto increase consumption of cholesterol-loweringfunctional foods including soy foods, nuts, andviscous fiber sources such as oats and barley. A sec-ond treatment group received a weekly food basket(Food Share, Toronto, Ontario) for 6 months, reflect-ing the advice given to the first treatment group butdid not receive dietary advice. A third treatmentgroup received both the weekly food basket and di-etary advice. All members of the same family wereexpected to follow the same treatment. Exercisepatterns were recorded but no additional advice wasgiven (Figure 1). The effect of advice to avoid sugar-sweetened beverages was also assessed using afactorial design with the addition of a treatmentgroup that involved sugar sweetened beverage advicealone. The effect of sugar-sweetened beverage advicewill be reported separately.

BIOCHEMICAL AND DIETARY ANALYSES. Biochem-ical analyses were performed in the St. Michael’sHospital (Toronto) routine laboratory. Participants’body weight was measured without shoes in lightindoor clothing on the same beam balance at eachclinic visit. Blood pressure was the mean of 3 readingsusing an automatic sphygmomanometer (Omron HEM907 XL, Omron Healthcare Inc., Burlington, Ontario,

Canada). The original validated semiquantitativefood frequency questionnaire of Willett et al. (11) wasexpanded to 184 food items to better capture wholegrains and viscous fiber products, including oats andbarley. Questionnaires were processed in the Nutri-tion Department, Harvard School of Public Health.

SAMPLE SIZE. The power calculation was based onhouseholds, and randomization was planned toassess dietary change. Sample size was calculatedusing Student’s t-test for independent observationsthat required 360 controls, 120 for dietary advice,120 for food delivery, and 120 for food delivery anddietary advice (Online Methods 1).

RANDOMIZATION. Randomization took place be-tween November 2005 and August 2009 to control or1 of the 3 dietary treatment groups to achieve anapproximately 3:1:1:1 ratio for the control and the 3dietary interventions, respectively. Participants wererandomized as households (assuming an average of 2family members per household), and all members ofthe same household received the same treatment. Astatistician not involved in the day-to-day operationof the interventions created blocks of random as-signments (n ¼ 39). Assignments were sealed in or-dered, numbered, opaque envelopes. Upon consentand eligibility confirmation for the individual orhousehold, the coordinator opened each envelope insequence and assigned the participant to the treat-ment group it contained. To allow for assessment ofthe effect of advice to reduce consumption of sugar-sweetened beverages (to be reported separately), afactorial design was used with the addition of an ex-tra cell of 60 households given only this advice. Theirdata are reported as part of the control group in thepresent study.

STATISTICS. Means and 95% confidence intervals(CIs) are provided. Body weight change was the pri-mary outcome. To model change, the dependentvariable was the end-of-study value with treatment(categorical) and the baseline value as independentvariables in a mixed model ANCOVA (PROC MIXED),SAS version 9.4 software (Cary, North Carolina). ATukey correction was applied for multiple compari-sons where significance was found. We used an ITT(intention-to-treat) analysis that accounted for dropouts using multiple imputation (5 sets) and a mono-tone predictive mean matching method (PROC MI)modeled with visit, age, sex, baseline weight andheight, smoking status, income, education, andbaseline outcome as covariates (Online Methods 2and 3). Results from the 5 imputations were pooledusing PROC MIANALYZE. To address correlated ob-servations within families, we added a random effect

FIGURE 1 Participant Flow Diagram

Advertising4,634 calls received

919 Randomized

Control*

n=486

6 monthsn=334

6 monthsn=89

6 monthsn=136

6 monthsn=126

108 dropout34 lost contact7 withdrawn†

3 no visit‡

40 dropout13 lost contact2 withdrawn†

1 no visit‡

6 dropout2 lost contact1 withdrawn†

3 no visit‡

7 dropout4 lost contact2 withdrawn†

1 no visit‡

10 dropout2 lost contact0 withdrawn†

10 dropout4 lost contact1 withdrawn†

10 dropout3 lost contact4 withdrawn†

35 dropout19 lost contact0 withdrawn†

18 months*

n=28318 months*

n=7818 months*

n=12418 months*

n=110

Advice*

n=145Food*

n=148Food & Advice*

n=140

*Households at baseline ¼ 441 control, 127 advice, 126 food, 125 food and advice; at 18 months ¼ 260 control, 67 advice, 105 food, 100 food and advice.

†Withdrawn due to medical reasons, pregnancy, or participating in another study. ‡Did not attend the 6-month intervention visit but attended the

18-month follow-up visit. Participants who missed their 6-month visit (n ¼ 8) were added to the 18-month visit.

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term to the statistical model to account for familyunit. Framingham coronary heart disease (CHD) riskscores were calculated (12) using participants’ age atbaseline. Dietary data were analyzed using ANCOVA,using all available data. Two further assessments ofthe data were also undertaken. First to assess theoutcomes using household as the unit of analysis, themean values of each household were taken and sec-ondly those participants whose BMI was <25 kg/m2

(n ¼ 36) were removed from the analysis, and againthe data were reanalyzed.

RESULTS

SIX-MONTH OUTCOMES. A total of 919 participantswere randomized (209 men, 710 women; mean age:44.7 years, and BMI: 32.4 kg/m2) (Online Table 1).A total of 722 were randomized as single-memberhouseholds, 94 as 2-member households (n ¼ 188),and 3 as 3-member households (n ¼ 9). A total of

685 participants completed 6 months (170 men, 515women), equating to a 75% retention rate (Figure 1).

When “food provided” was compared to “no foodprovided,” a major difference was seen in retentionfavoring food provision, with 91% retention for thosewith food provision versus 67% (p < 0.0001) forthose without food provision completing the 6-monthactive intervention.

SIX-MONTH CHANGE IN DIETARY INTAKE. At 6 months,only small increases were seen in intake of fruit (0.3 to1.1 servings/day), vegetables (0.4 to 1.3 servings/day),and whole grains (0.0 to 1.0 servings/day) (Figure 2,Online Table 2). The increases in intake in the treat-ment groups compared to the control were evensmaller, with only food provision plus advice showingconsistent increases in fruit, vegetables, and wholegrain cereals (Online Table 3). The differences were0.8, 0.9, and 0.9 servings/day, respectively, for the 3treatments (Figure 2). Other treatment differences,where they occurred, were small (Online Table 3).

FIGURE 2 Changes in Servings of Fruit, Vegetable, and Whole Grains Intake by

Treatment at 6 Months

Fruit

Serv

ings

6 Month Changes in Diet Components

Vegetable

*

*

*

*

*

*

Control Advice only Food only Food and advice

Whole Grains

1.4

1.2

0.8

0.6

0.4

0.2

0

1

*Significantly different from control group (p < 0.05).

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The same pattern of very small increases was seenwith the so-called functional, cholesterol-lowering,foods (nuts, viscous fiber, and soy protein foods).Thus the maximum increase in nut intake was only6.5 g/day (under one-quarter of an ounce) followingfood delivery plus advice (Online Table 2).

SIX-MONTH OUTCOMES: BODY WEIGHT AND CHD

RISK FACTORS. Overall, at 6 months, the cohortshowed small reductions in body weight (�1.0 kg),waist circumference (�1.4 cm), and blood pressure(diastolic: �0.8 mm Hg and mean arterialpressure: �0.7 mm Hg) (Table 1). Similar reductionswere seen on the control and individual test treat-ments for body weight (�0.8 to �1.2 kg), waistcircumference (�1.1 to �1.9 cm), and blood pressure(diastolic: �0.1 to �1.0 mm Hg, and mean arterialpressure: 0.0 to �1.1 mm Hg) (Table 2). The withintreatment differences in body weight and waistcircumference were significant for the control andtest treatments (Central Illustration).

The only other significant reductions were for bothdiastolic blood pressure and mean arterial bloodpressure on control (�1.0 mm Hg, p ¼ 0.002, and �0.9mm Hg, p ¼ 0.042, respectively) (Table 2). However,there were no significant treatment differences for anyof the outcome measurements between any of the4 groups (control and 3 treatments) (Online Table 4).

DIFFERENCES AND “LEGACY EFFECTS” AT 18

MONTHS. At 18 months, the overall retention was65%, including 81% for those provided with food and57% for those without food provision. Only small in-creases from baseline remained for fruit (0.4 to 0.6servings/day), vegetables (0.3 to 0.6 servings/day),and whole grain cereals (0 to 0.6 servings/day). Theseincreases were significantly reduced from the alreadymodest 6-month increases (Online Figure 1, OnlineTable 5). The same pattern was seen with thecholesterol-lowering functional foods, for example,for nuts, the increase was reduced at 18 months tobetween 3.3 and 4.7 g/day on the test treatments,and when compared to the control increase of3.6 g/day, these differences became negligible(�0.8 to 1.3 g/day) (Online Table 3).

For the whole cohort, the reductions in bodyweight, BMI and waist circumference that were seenat 6 months were maintained (Online Table 6). High-density lipoprotein cholesterol (HDL-C) rose between6 and 18 months (0.05 mmol/l, p < 0.0001) and thetotal-to-HDL-C ratio was reduced. Reduction in bloodpressure at 6 months was further reduced signifi-cantly between 6 and 18 months, with the reductionsin the Framingham CHD risk score becoming signifi-cant at 18 months (Online Table 6). These differences

were also reflected in the individual treatment re-sponses (Online Figure 2), with no significant treat-ment differences either between the 18-monthchanges from baseline or between the 6 to 18 monthsdifferences (Online Tables 4 and 7).

ADDITIONAL ANALYSES. No outcome differences at6 and 18 months were uncovered by assessing thedata by using household as the unit of analysis or byeliminating those family members who had bodyweights in the normal range (Online Tables 8 and 9).

ADVERSE EVENTS. There were 24 serious adverseevents according to the Code of Federal Regulations(13) (7 control, 11 food basket and dietary advice,4 food basket only, and 2 dietary advice only) (OnlineTable 10). After adjustment for length of participanttime in the study the difference between the pooledtest and control treatments failed to reach signifi-cance (p ¼ 0.068). However, separate assessment ofgastrointestinal-related events indicated significantlymore events among test participants thancontrol participants: 7 versus 0. Adverse eventswere cholecystectomy (n ¼ 3), appendectomy (n ¼ 2),hiatal hernia repair (n ¼ 1), and diverticulitis (n ¼ 1),p ¼ 0.005 (Online Table 10).

DISCUSSION

These data demonstrate the difficulty in effectivelypromoting fruit, vegetable, and whole grain cereals to

TABLE 1 Mean Baseline Values and Changes in Outcomes at 6 Months for All Participants*

N

Baseline 6 Months 6-Month Change

Mean 95% CI Mean 95% CI Mean 95% CI Pr > |t|†

Weight, kg 919 88.2 87.0 to 89.3 87.1 86.0 to 88.3 �1.0 �1.4 to �0.7 <0.0001

BMI, kg/m2 919 32.4 32.1 to 32.8 32.1 31.7 to 32.5 �0.4 �0.5 to �0.2 <0.0001

Waist, cm 919 101.4 100.5 to 102.3 100.0 99.0 to 101.0 �1.4 �1.9 to �0.9 <0.0001

Glucose, mmol/l 919 4.82 4.78 to 4.85 4.83 4.78 to 4.87 0.01 �0.03 to 0.04 0.648

Total cholesterol, mmol/l 919 5.06 5.00 to 5.12 5.01 4.94 to 5.08 �0.05 �0.10 to 0.01 0.097

LDL-C, mmol/l 915 3.23 3.18 to 3.28 3.19 3.13 to 3.24 �0.04 �0.08 to 0.00 0.062

HDL-C, mmol/l 919 1.28 1.26 to 1.31 1.27 1.25 to 1.29 �0.01 �0.03 to 0.00 0.108

Triglycerides, mmol/l 919 1.21 1.16 to 1.25 1.22 1.17 to 1.27 0.01 �0.03 to 0.05 0.593

Total cholesterol/HDL 919 4.16 4.09 to 4.23 4.15 4.08 to 4.23 �0.01 �0.05 to 0.04 0.830

Non-HDL cholesterol, mmol/l 919 3.77 3.72 to 3.83 3.74 3.67 to 3.80 �0.03 �0.08 to 0.01 0.112

Systolic blood pressure, mm Hg 919 114.6 113.8 to 115.4 114.0 113.1 to 114.8 �0.6 �1.3 to 0.1 0.085

Diastolic blood pressure, mm Hg 918 73.0 72.4 to 73.5 72.1 71.5 to 72.7 �0.8 �1.3 to �0.4 <0.001

Mean arterial pressure, mm Hg 918 86.8 86.2 to 87.4 86.1 85.4 to 86.8 �0.7 �1.3 to �0.1 0.019

10-yr CHD risk % 919 3.58 3.32 to 3.84 3.48 3.22 to 3.74 �0.10 �0.21 to 0.02 0.098

*To convert the values to milligrams per deciliter, divide cholesterol by 0.0259, triglycerides by 0.0113, and glucose by 0.0555. †p values in boldface indicate significance.

BMI ¼ body mass index; CHD ¼ coronary heart disease; HDL ¼ high-density lipoprotein; LDL ¼ low-density lipoprotein.

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the general population, using recommendations that,when followed, decrease risk factors for chronic dis-ease (Central Illustration). They indicate an urgentneed for innovative approaches to support theimplementation of current dietary advice (5,6,14,15).

Our findings are supported by a meta-analysis ofsmaller shorter studies, beginning in 1998, thatshowed no change in body weight compared to thecontrol treatment even when fruit and vegetableswere provided (16,17). However our results contrastwith trials in participants at higher risk (8). One trial of345 participants with hypercholesterolemia, many ofwhom had been given a statin “holiday,” showed low-density lipoprotein cholesterol (LDL-C) reductions of13% to 14% with corresponding 41% to 46% adherenceto a dietary portfolio of cholesterol-lowering foods (8),as opposed to only 12% adherence in the presentstudy. In this respect, a very recent large (543 partici-pants) comprehensive lifestyle peer group-basedintervention on cardiovascular risk factors also foundno significant effect on individual risk factors,although due to a major success in smoking cessation,a reduction in estimated cardiovascular risk was ach-ieved (18). In that trial 31% of participants smokedcompared to 7.8% in the current study. Smokingcessation, exercise, and stress management were notpart of our purely dietary intervention.

ADVERSE EVENTS. Those given advice plus the foodbasket suffered an excess of gastrointestinal side ef-fects. Although the diets prescribed are recom-mended for long-term gastrointestinal health, it ispossible that the acute increase in fiber from cereals,fruits, and vegetables may have caused some

abdominal discomfort and drawn attention to pre-existing conditions. The increase in fiber intakecompared to the control at 6 months was 8.2 g/dayextra for a 2,000 kcal diet. This fiber intake wasequivalent to 4 slices of whole wheat bread daily.However, these participants were already accus-tomed to a reasonable fiber intake at baseline(25.4 g/day), and problems were not anticipatedwith higher fiber diets.

FACTORS FAVORING LIFESTYLE CHANGE. The suc-cess of dietary advice may be influenced by theperception of immediate benefit from the interven-tion. Further emphasis is therefore required on thelonger term health advantages of sustaining a gooddiet for otherwise healthy people, as has beendemonstrated in cohort studies with long-termfollow-up (19,20). Usual diets may also representstable “habits” that are resistant to change withoutspecific personal and environmental supports (21).Thus more emphasis should be placed on overcomingbarriers related to methods of food preparation and inillustrating those situations in which the desiredfoods can be eaten (meals and snacks). Addressingthese issues in cafeteria trials where entire mealswere fed to healthy people addressed the issue of dietadherence and demonstrated that lower body weightand blood lipids can be achieved in the long term (22).Consumption of nuts has increased considerablysince the repeated demonstration of their cholesterol-lowering potential, their possible CHD risk reductionproperties in cohort studies, and recently, in a ran-domized controlled trial (23–25). However this seculartrend did not increase our success in promoting

TABLE 2 Mean Values and Changes (95% CI) in Outcomes at Baseline and 6 Months for All Participants, by Treatment Group*

Control (n ¼ 486) Food Only (n ¼ 148)

Baseline 6 Months 6 Months D Pr > |t|† Baseline 6 Months 6 Months D Pr > |t|†

Weight, kg 88 (86.5 to 89.5) 87 (85.5 to 88.5) �1 (�1.5 to �0.5) <0.001 89.2 (86.3 to 92.2) 88 (85.1 to 91) �1.2 (�1.9 to �0.4) 0.002

BMI, kg/m2 32.5 (32 to 33) 32.2 (31.7 to 32.7) �0.3 (�0.5 to �0.2) <0.001 32.6 (31.6 to 33.5) 32.2 (31.3 to 33.2) �0.4 (�0.6 to �0.1) 0.015

Waist, cm 101.2 (100 to 102.5) 100 (98.7 to 101.3) �1.2 (�1.9 to �0.6) <0.001 102.3 (99.8 to 104.8) 100.4 (97.9 to 102.9) �1.9 (�2.8 to �1) <0.0001

Glucose, mmol/l 4.81 (4.77 to 4.86) 4.83 (4.77 to 4.9) 0.02 (�0.04 to 0.08) 0.507 4.8 (4.71 to 4.89) 4.82 (4.72 to 4.91) 0.02 (�0.06 to 0.1) 0.657

Total cholesterol, mmol/l 5.09 (5 to 5.17) 5.03 (4.92 to 5.14) �0.05 (�0.14 to 0.03) 0.204 5 (4.87 to 5.14) 4.96 (4.82 to 5.11) �0.04 (�0.14 to 0.06) 0.400

LDL-C, mmol/l 3.27 (3.19 to 3.34) 3.22 (3.13 to 3.32) �0.04 (�0.12 to 0.04) 0.266 3.17 (3.06 to 3.29) 3.17 (3.04 to 3.29) 0 (�0.09 to 0.08) 0.913

HDL-C, mmol/l 1.27 (1.24 to 1.3) 1.26 (1.23 to 1.29) �0.01 (�0.03 to 0.01) 0.337 1.27 (1.21 to 1.32) 1.27 (1.21 to 1.32) 0 (�0.04 to 0.03) 0.969

Triglycerides, mmol/l 1.23 (1.16 to 1.29) 1.22 (1.14 to 1.3) �0.01 (�0.06 to 0.05) 0.819 1.21 (1.1 to 1.32) 1.2 (1.09 to 1.31) �0.01 (�0.11 to 0.08) 0.801

Total cholesterol/HDL 4.2 (4.1 to 4.3) 4.2 (4.09 to 4.3) 0 (�0.07 to 0.06) 0.934 4.19 (3.99 to 4.38) 4.17 (3.96 to 4.37) �0.02 (�0.12 to 0.08) 0.686

Non-HDL cholesterol, mmol/l 3.81 (3.73 to 3.9) 3.78 (3.69 to 3.87) �0.04 (�0.1 to 0.02) 0.230 3.73 (3.6 to 3.87) 3.7 (3.55 to 3.84) �0.04 (�0.13 to 0.05) 0.414

Systolic blood pressure, mm Hg 114.7 (113.6 to 115.8) 113.9 (112.7 to 115) �0.9 (�1.8 to 0) 0.063 114.6 (112.7 to 116.5) 114.8 (113 to 116.5) 0.2 (�1.3 to 1.7) 0.789

Diastolic blood pressure, mm Hg 73.3 (72.5 to 74) 72.2 (71.4 to 73.1) �1 (�1.7 to �0.4) 0.002 72.9 (71.6 to 74.2) 72.1 (70.8 to 73.4) �0.8 (�1.9 to 0.3) 0.155

Mean arterial pressure, mm Hg 87.1 (86.2 to 87.9) 86.2 (85.2 to 87.2) �0.9 (�1.7 to 0) 0.042 86.8 (85.4 to 88.2) 86.3 (84.9 to 87.7) �0.5 (�1.7 to 0.7) 0.383

10-yr CHD risk % 3.55 (3.21 to 3.89) 3.5 (3.15 to 3.85) �0.05 (�0.19 to 0.09) 0.480 3.82 (3.1 to 4.54) 3.66 (3 to 4.33) �0.16 (�0.38 to 0.07) 0.175

Advice Only (n ¼ 145) Food and Advice (n ¼ 140)

Baseline 6 Months 6 Months D Pr > |t| Baseline 6 Months 6 Months D Pr > |t|

Weight, kg 86.2 (83.3 to 89.1) 85 (82 to 88) �1.2 (�2.4 to 0) 0.044 89.6 (86.6 to 92.6) 88.7 (85.6 to 91.9) �0.8 (�1.7 to 0) 0.049

BMI, kg/m2 31.7 (30.8 to 32.7) 31.3 (30.3 to 32.2) �0.4 (�0.7 to �0.1) 0.004 32.7 (31.7 to 33.7) 32.4 (31.3 to 33.4) �0.3 (�0.7 to 0) 0.065

Waist, cm 100.6 (98.3 to 102.8) 98.7 (96.2 to 101.3) �1.8 (�3.2 to �0.5) 0.012 101.9 (99.5 to 104.3) 100.8 (98.3 to 103.4) �1.1 (�2.2 to 0) 0.047

Glucose, mmol/l 4.87 (4.77 to 4.97) 4.85 (4.74 to 4.96) �0.02 (�0.11 to 0.07) 0.632 4.81 (4.72 to 4.9) 4.8 (4.71 to 4.89) �0.01 (�0.08 to 0.07) 0.873

Total cholesterol, mmol/l 5.17 (5.02 to 5.32) 5.17 (4.98 to 5.37) 0 (�0.16 to 0.16) 1.000 4.89 (4.74 to 5.04) 4.82 (4.66 to 4.99) �0.07 (�0.17 to 0.04) 0.200

LDL-C, mmol/l 3.3 (3.17 to 3.43) 3.27 (3.13 to 3.4) �0.04 (�0.13 to 0.06) 0.458 3.07 (2.94 to 3.2) 3 (2.85 to 3.14) �0.08 (�0.17 to 0.02) 0.113

HDL-C, mmol/l 1.32 (1.26 to 1.39) 1.3 (1.24 to 1.36) �0.02 (�0.06 to 0.01) 0.243 1.3 (1.24 to 1.36) 1.28 (1.22 to 1.33) �0.02 (�0.06 to 0.02) 0.264

Triglycerides, mmol/l 1.2 (1.1 to 1.31) 1.25 (1.13 to 1.37) 0.05 (�0.05 to 0.14) 0.351 1.14 (1.03 to 1.26) 1.2 (1.09 to 1.32) 0.06 (�0.03 to 0.14) 0.184

Total cholesterol/HDL 4.16 (3.97 to 4.35) 4.19 (3.98 to 4.4) 0.03 (�0.12 to 0.17) 0.726 3.99 (3.8 to 4.18) 3.96 (3.76 to 4.16) �0.03 (�0.17 to 0.12) 0.696

Non-HDL cholesterol, mmol/l 3.85 (3.71 to 3.99) 3.85 (3.69 to 4) 0 (�0.1 to 0.1) 0.968 3.59 (3.45 to 3.74) 3.54 (3.38 to 3.7) �0.06 (�0.16 to 0.05) 0.299

Systolic blood pressure, mm Hg 114.8 (112.8 to 116.7) 113.4 (111.2 to 115.6) �1.3 (�3.2 to 0.5) 0.147 114 (111.8 to 116.1) 114 (111.8 to 116.2) 0.1 (�1.7 to 1.9) 0.940

Diastolic blood pressure, mm Hg 72.2 (70.8 to 73.6) 71.3 (69.6 to 73) �0.9 (�2.2 to 0.3) 0.145 72.7 (71.2 to 74.2) 72.5 (70.9 to 74.1) �0.1 (�1.3 to 1) 0.841

Mean arterial pressure, mm Hg 86.4 (84.9 to 87.9) 85.3 (83.5 to 87.1) �1.1 (�2.6 to 0.4) 0.136 86.5 (84.9 to 88.1) 86.4 (84.7 to 88.1) 0 (�1.3 to 1.3) 0.995

10-yr CHD risk % 4.03 (3.35 to 4.71) 3.85 (3.15 to 4.55) �0.19 (�0.58 to 0.21) 0.339 2.94 (2.29 to 3.59) 2.83 (2.26 to 3.41) �0.11 (�0.36 to 0.15) 0.420

*To convert the values to milligrams per deciliter, divide cholesterol by 0.0259, triglycerides by 0.0113 and glucose by 0.0555. †p Values in boldface indicate significance.

Abbreviations as in Table 1.

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CENTRAL ILLUSTRATION Current Dietary Recommendations on Weight Loss and Cardiovascular Risk Factor

Jenkins, D.J.A. et al. J Am Coll Cardiol. 2017;69(9):1103–12.

Six-month changes in study outcomes. Mean change and 95% confidence limit. *Significant change from baseline p < 0.05.

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nut intake by our group. Research must thereforecontinue to be funded to clearly establish the benefitof dietary strategies on health outcomes that, afterpublication, can be taken up by the media and hence

the general public. The successful PREDIMED(PREvencion con DIeta MEDiterranea) study providednuts and olive oil freely to participants (23). Shouldhealthy foods also be subsidized for the general

PERSPECTIVES

COMPETENCY IN SYSTEMS-BASED PRACTICE: Although

fruit, vegetables, and whole grain cereals are part of dietary

advice given internationally, foods containing soy protein, nuts,

viscous fiber sources (oats, barley, psyllium), and plant sterols

(e.g., as in enriched margarine) have been approved by the U.S.

Food and Drug Administration for heart health claims since they

specifically lower serum cholesterol.

TRANSLATIONAL OUTLOOK: Dietary change is difficult in

relatively healthy populations and may take community-based

strategies to implement effectively, but even limited patient

instructions, including pamphlets and guidelines from national

public health agencies may lead to reductions in body weight and

coronary heart disease risk scores.

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population? In the present study, provision of foodsvery significantly increased retention. Although thisapproach only resulted in modest increases in con-sumption of recommended foods or reductions instudy outcomes, retention itself may be an indicationof continued adherence.

Finally, should the ecological sustainability ad-vantages of increased plant food consumption beemphasized? Sustainability considerations areincreasingly alluded to in current dietary guide-lines and science advisory reports internationally(3,26), and may increase the appeal to younger andhealthier people, similar to our participants.

ADHERENCE IN THE PRESENT STUDY. Using theabove ideas, adherence in our study might havebeen improved if our participants had had compel-ling reasons to change their dietary habits,including raised LDL-C or elevated blood pressure(baseline LDL-C: 3.23 mmol/l, and blood pressure:115/73 mm Hg in the present study). Furthermore,provision of complete diets or use of workplacecafeteria to provide meals incorporating DASH andportfolio dietary principles, plus a comprehensiveeducational program on the value of food in themaintenance of good health, might also have beenhelpful.

STUDY LIMITATIONS. A significant limitation of thestudy was the differential dropout rate between thetreatment arms, with a 6-month retention of 91% inthe 2 food delivery arms versus 67% when no foodwas provided. Similar effects of food provision havebeen seen in longer diet trials such as the PREDIMEDtrial where provision of nuts or olive oil was associ-ated with enhanced retention (23), and high retentionrates commonly observed in drug trials may relate inpart to the free provision of the intervention. It isinteresting that in our study there also appeared to bea “legacy effect” in that when no food was provided,prior provision of food still resulted at 18 months inan 81% retention versus 57% where no food had beenprovided.

A second limitation was the provision of Canada’sFood Guide, which may have had beneficial effectsin increasing intake of the desired foods in thecontrol group; however, the changes observed weresmall. Furthermore, we did not recruit sufficientfamily members to allow the assessment of familyinfluences on dietary change. Third, as the partici-pants were generally healthy at baseline, with 18%of participants who belonged to 2- or 3-memberfamily units already at a healthy body weight (4% of

total group), changes in risk factors may have beenmore difficult to detect and so limited our ability tosee an effect.

STRENGTHS. One strength of our study is that it isthe first to encourage specific food consumption byproviding both dietary advice and a range of foodsthat included less familiar functional foods. It isalso the first to do so in the context of DASH andportfolio dietary approaches, and determine theeffects on body weight and risk factors for CHD. Inaddition it demonstrated that removal of certainpotential barriers to consumption including avail-ability and familiarity (e.g., soy products) wasnot enough to increase substantially the use ofdesired foods in overweight but otherwise healthypeople.

CONCLUSIONS

Increasing the intake of not only fruit, vegetables,and whole grain cereals but also functional foodsproved difficult (27), even when these foods wereprovided weekly and despite the known effectivenessof such foods in managing CHD risk factors. Healthyshifts in diet among generally well populations islikely to require a range of sustained approaches andmultiple forms of communication in a processmeasured in decades rather than months (10).

ADDRESS FOR CORRESPONDENCE: Dr. David J.A.Jenkins, Department of Nutritional Sciences, Univer-sity of Toronto, 150 College Street, Fitzgerald Build-ing, Toronto, Ontario M5S 3E2, Canada. E-mail:nutritionproject@smh.ca.

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KEY WORDS body weight, cardiovasculardisease, diet, dietary recommendations,risk factors

APPENDIX For an expanded Methods sectionand additional tables and figures, please see theonline version of this article.