nine-day weight loss program with high protein shakes

1
® Nine-day weight loss program with high protein shakes supplemented with herbal beverage in dry mix powder or liquid form on fasting days leads to healthy weight loss Mary Balliett 1 , Jeanmarie R. Burke 2 , Oscar Rasmussen 3 , Susie Rockway 4 . 1 Basic Sciences, 2 Director of Research, New York Chiropractic College, Seneca Falls, NY, 3 Nutricons, New Milford, CT, 4 Director of Research, Isagenix International, LLC, Chandler, AZ Introduction Intermittent calorie restriction (ICR) has demonstrated several advantages on the health of animals, similar to calorie restriction and alternate-day fasting, including extended lifespan and protection against cardiovascular disease, type 2 diabetes, asthma and cancers (1-5). This pilot study evaluates a novel weight-loss system that combines ICR (water fasting with an herbal beverage Isagenix Cleanse for Life®) and, on non-fasting days, replacement of two of three meals with a high-protein shake (IsaLean Shake ~240kcal @) and consumption of one low-glycemic meal (400- 600 kcal). References: 1. Heilbronn et al. Calorie restriction and aging: review of the literature and implications for studies in humans. Am J Clin Nutr 78:361-369; 2003. 2. Mattison et al. Calorie restriction in rhesus monkeys. Exp. Gerontol. 38 :35-46 ; 2003 3. Fontana, et al. Long-term calorie restriction is highly effective in reducing the risk of atherosclerosis in humans. Proc. Natl. Acad. Sci. USA 101:6659-6663; 2004. 4. Goodrick et al. Effects of intermittent feeding upon growth and life span in rats. Gerontology 28:233-341;1982. 5. Anson, et al. Intermittent fasting dissociates beneficial effects of dietary restriction on glucose metabolism and neuronal resistance to injury from calorie intake. Prec Natl Acad Sci USA Table 1. Anthropometric measurements for 41 subjects* following 9-day weight- loss program Day 0 (Baseline) Day 10 Change from baseline Body Weight (lbs) 174 ± 42 167 ± 40 -7* BMI (kg/m 2 ) 28 ± 7 27 ± 7 -1 * Waist Circumference (in) 35 ± 6 35 ± 6 -0.6* Hip Circumference (in) 42 ± 5 41 ± 5 -0.7* Waist/Hip Ratio 0.8 ± 0.1 0.8 ± 0.1 No change Males 8; Females 33; age: 36 ± 13 years *p ≤ 0.05 Table 2. Body composition changes from baseline after 9-day weight-loss program Day 0 (Baseline) Day 10 Change from baseline Fat Mass (lbs) 54 ± 42 51 ± 23 -3* Fat Mass (%) 30 ± 7 30 ± 8 -1 * Lean Body Mass (lbs) 120 ± 25 117 ± 24 -3* Lean Body Mass (%) 70 ± 7 71 ± 8 1* Total Body Water (L) 39 ± 9 38 ± 8 -1* Intracellular Water (L) 22 ± 6 21 ± 6 -0.4* Intracellular Water (%) 54 ± 4 55 ± 4 -1* Extracellular Water (L) 18 ± 4 17 ± 3 -1* Extracellular Water (%) 46 ± 4 45 ± 4 -1* *p ≤ 0.05 Abstract Aim. To evaluate a nine-day weight-loss program consisting of fasting days supplemented with a novel herbal beverage in dry powder mix or ready-to-drink liquid form on body composition and blood parameters in healthy adults. Design. The study randomized 42 healthy adults to one of two groups. Group 1 received herbal beverage from powder mix while Group 2 received ready-to-drink liquid. Both groups fasted with 64 oz of water and 16 oz of herbal beverage in two-day intervals separated by five non-fasted days in which subjects ate one meal and replaced two others with a meal-replacement high-protein shake. Measurements and blood were taken days 0 and 10. Statistics. ANOVA for repeated measures was performed initially; however, no differences between groups were detected for any measure, thus, data for both groups were pooled. Results. The average weight loss of subjects was 6.6 lbs (3.8% of initial body weight) and was statistically significant (p<0.05) from baseline weight (174 ± 42). Waist and hip circumference decreased significantly by 0.6 and 0.7 inches, respectively, from baseline. Both lean and fat body mass decreased by 3.2 and 2.9 lbs, respectively. Total-, LDL- cholesterol and TG decreased significantly by 17.8, 8.3 mg/dl and 25.6 mg/dL, respectively. Subjects lost weight and felt better about their body weight and energy level. Products and funding were provided by Isagenix International, LLC. Abstract Number: 8398 Program Number: LB335 Summary Significant decreases from baseline (p<0.05) were found in the following outcome measures: • Weight loss -- 6.6 lbs • Waist circumference -- 0.6 in • Hip measurement -- 0.7 in • Lean body mass -- 3.2 lbs • Fat body mass -- 2.9 lbs • Total cholesterol -- 17.8 mg/dL • LDLs -- 8.3 mg/dL • TAGs -- 25.6 mg/dL Subjects felt better about their body weight and had higher energy levels. No differences were found between the group taking Cleanse for Life® in powder or liquid form Table 3. Changes in fasting blood glucose and lipid levels in subjects after 9-day weight-loss program Day 0 (Baseline) Day 10 Change from baseline Glucose (mg/dL) 89 ± 7 84 ± 10 -5.0* Total Cholesterol (mg/dL) 190 ± 411 172 ± 39 -18* HDL (mg/dL) 50 ± 12 45 ± 12 -4.5* TAG (mg/dL) 110 ± 48 84 ± 34 -26* LDL (mg/dL) 118.08 ± 39.99 109.75 ± 37.31 -8.33* *p ≤ 0.05 Table 4. Changes for Visual Analog Scale (VAS) expressing energy level, weight issues and GI distress in subjects at baseline and after 9-day weight loss program Day 0 (Baseline) Day 10 Change from baseline VAS (0 – 100 mm) Energy Level 61 ± 18 68 ± 21 6.4 Weight Issues 39 ± 24 48 ± 19 8.8* Gastrointestinal Distress 72 ± 23 63 ± 27 -8.8 *p ≤ 0.05 Conclusion The feasibility of combining a fasting regime with meal replacement shakes as a quick-start weight-loss system proved to be effective and well-tolerated. Methods Design: 42 healthy adults were randomized to one of two groups and run parallel Group 1: received herbal beverage from powder mix Group 2: received ready-to-drink liquid day 0 1 2 3 4 5 6 7 8 9 10 Fasting Days 8X/d 8-oz. water 4X/d 4-oz. herb drink Shake Days 2X/d protein shake 1X/d ≈400 - 600 kcal low-GI meal 8X/d 8-oz. water Fasting Days 8X/d 8-oz. water 4X/d 4-oz. herb drink No food after 8pm AM blood draw; Anthro measure AM blood draw: Anthro measure

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Nine-day weight loss program with high protein shakes supplemented with herbal beverage in dry mix powder or liquid form on fasting days leads to healthy weight loss

Mary Balliett1, Jeanmarie R. Burke2, Oscar Rasmussen3, Susie Rockway4.1Basic Sciences, 2Director of Research, New York Chiropractic College, Seneca Falls, NY, 3Nutricons, New Milford, CT, 4Director of Research, Isagenix International, LLC, Chandler, AZ

IntroductionIntermittent calorie restriction (ICR) has demonstrated several advantages on the health of animals, similar to calorie restriction and alternate-day fasting, including extended lifespan and protection against cardiovascular disease, type 2 diabetes, asthma and cancers (1-5). This pilot study evaluates a novel weight-loss system that combines ICR (water fasting with an herbal beverage Isagenix Cleanse for Life®) and, on non-fasting days, replacement of two of three meals with a high-protein shake (IsaLean Shake ~240kcal @) and consumption of one low-glycemic meal (400-600 kcal).

References:

1. Heilbronn et al. Calorie restriction and aging: review of the literature and implications for studies in humans. Am J Clin Nutr 78:361-369; 2003.

2. Mattison et al. Calorie restriction in rhesus monkeys. Exp. Gerontol. 38 :35-46 ; 2003

3. Fontana, et al. Long-term calorie restriction is highly effective in reducing the risk of atherosclerosis in humans. Proc. Natl. Acad. Sci. USA 101:6659-6663; 2004.

4. Goodrick et al. Effects of intermittent feeding upon growth and life span in rats. Gerontology 28:233-341;1982.

5. Anson, et al. Intermittent fasting dissociates beneficial effects of dietary restriction on glucose metabolism and neuronal resistance to injury from calorie intake. Prec Natl Acad Sci USA

Table 1. Anthropometric measurements for 41 subjects* following 9-day weight- loss program

Day 0 (Baseline) Day 10Change from

baseline

Body Weight (lbs) 174 ± 42 167 ± 40 -7*

BMI (kg/m2) 28 ± 7 27 ± 7 -1 *

Waist Circumference (in) 35 ± 6 35 ± 6 -0.6*

Hip Circumference (in) 42 ± 5 41 ± 5 -0.7*

Waist/Hip Ratio 0.8 ± 0.1 0.8 ± 0.1 No change

Males 8; Females 33; age: 36 ± 13 years *p ≤ 0.05

Table 2. Body composition changes from baseline after 9-day weight-loss program

Day 0 (Baseline) Day 10Change from

baseline

Fat Mass (lbs) 54 ± 42 51 ± 23 -3*

Fat Mass (%) 30 ± 7 30 ± 8 -1 *

Lean Body Mass (lbs) 120 ± 25 117 ± 24 -3*

Lean Body Mass (%) 70 ± 7 71 ± 8 1*

Total Body Water (L) 39 ± 9 38 ± 8 -1*

Intracellular Water (L) 22 ± 6 21 ± 6 -0.4*

Intracellular Water (%) 54 ± 4 55 ± 4 -1*

Extracellular Water (L) 18 ± 4 17 ± 3 -1*

Extracellular Water (%) 46 ± 4 45 ± 4 -1*

*p ≤ 0.05

AbstractAim. To evaluate a nine-day weight-loss program consisting of fasting days supplemented with a novel herbal beverage in dry powder mix or ready-to-drink liquid form on body composition and blood parameters in healthy adults.

Design. The study randomized 42 healthy adults to one of two groups. Group 1 received herbal beverage from powder mix while Group 2 received ready-to-drink liquid. Both groups fasted with 64 oz of water and 16 oz of herbal beverage in two-day intervals separated by five non-fasted days in which subjects ate one meal and replaced two others with a meal-replacement high-protein shake. Measurements and blood were taken days 0 and 10.

Statistics. ANOVA for repeated measures was performed initially; however, no differences between groups were detected for any measure, thus, data for both groups were pooled.

Results. The average weight loss of subjects was 6.6 lbs (3.8% of initial body weight) and was statistically significant (p<0.05) from baseline weight (174 ± 42). Waist and hip circumference decreased significantly by 0.6 and 0.7 inches, respectively, from baseline. Both lean and fat body mass decreased by 3.2 and 2.9 lbs, respectively. Total-, LDL- cholesterol and TG decreased significantly by 17.8, 8.3 mg/dl and 25.6 mg/dL, respectively. Subjects lost weight and felt better about their body weight and energy level.

Products and funding were provided by Isagenix International, LLC.

Abstract Number: 8398Program Number: LB335

SummarySignificant decreases from baseline (p<0.05) were found in the following outcome measures:

• Weight loss -- 6.6 lbs

• Waist circumference -- 0.6 in

• Hip measurement -- 0.7 in

• Lean body mass -- 3.2 lbs

• Fat body mass -- 2.9 lbs

• Total cholesterol -- 17.8 mg/dL

• LDLs -- 8.3 mg/dL

• TAGs -- 25.6 mg/dL

Subjects felt better about their body weight and had higher energy levels.

No differences were found between the group taking Cleanse for Life® in powder or liquid form

Table 3. Changes in fasting blood glucose and lipid levels in subjects after 9-day weight-loss program

Day 0 (Baseline) Day 10Change from

baseline

Glucose (mg/dL) 89 ± 7 84 ± 10 -5.0*

Total Cholesterol (mg/dL) 190 ± 411 172 ± 39 -18*

HDL (mg/dL) 50 ± 12 45 ± 12 -4.5*

TAG (mg/dL) 110 ± 48 84 ± 34 -26*

LDL (mg/dL) 118.08 ± 39.99 109.75 ± 37.31 -8.33*

*p ≤ 0.05

Table 4. Changes for Visual Analog Scale (VAS) expressing energy level, weight issues and GI distress in subjects at baseline and after 9-day weight loss program

Day 0 (Baseline) Day 10Change from

baseline

VAS (0 – 100 mm)

Energy Level 61 ± 18 68 ± 21 6.4

Weight Issues 39 ± 24 48 ± 19 8.8*

Gastrointestinal Distress 72 ± 23 63 ± 27 -8.8

*p ≤ 0.05

ConclusionThe feasibility of combining a fasting regime with meal replacement shakes as a quick-start weight-loss system proved to be effective and well-tolerated.

MethodsDesign: 42 healthy adults were randomized to one of two groups and run parallelGroup 1: received herbal beverage from powder mixGroup 2: received ready-to-drink liquid

day 0 1 2 3 4 5 6 7 8 9 10

Fasting Days

8X/d 8-oz. water4X/d 4-oz. herb drink

Shake Days

2X/d protein shake1X/d ≈400 - 600 kcal low-GI meal

8X/d 8-oz. water

Fasting Days

8X/d 8-oz. water4X/d 4-oz. herb drink

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