Anti-Aging, Gut Microbiome, Weight Loss
Conditions
Brief summary
This study will systematically quantify the effects of protein pacing and intermittent fasting (P-IF) on total and regional (abdominal) body composition (lean mass and fat mass), blood glucose and lipids, and anti-aging biomarkers, hunger ratings, and the gut microbiome in 40 overweight/obese adult men (n=20) and women (n=20) following a 8-week weight loss intervention. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.
Detailed description
Previous research has shown combined protein pacing and intermittent fasting (PP-IF; 1-2 days per week) combined with moderate (20-30%) caloric restriction (CR) favorably enhance weight loss, body composition, cardiometabolic disease risk, oxidative stress, and toxin levels compared to a heart healthy diet in obese individuals following both weight loss and weight loss maintenance (Arciero et al. 2016; He et al. 2017; Zuo et al. 2016). However, less is known about whether a low sugar intake with this dietary pattern induces other significant health improvements, such as enhanced brain health (mood state), as well as gut microbiome and anti-aging indices, compared to a heart healthy diet. The novelty of the current proposal is of particular relevance and importance given the heightened popularity of low sugar dietary patterns shown to enhance health status. Most notably, among these low sugar diets touting the health benefits, are the ketogenic, paleolithic and Mediterranean diets. In addition, there is a great deal of public health emphasis on reducing overall carbohydrate intake, especially simple sugars, to improve cardiometabolic, gut, and body composition health. The dangers of high simple sugar intake are numerous, including increased risk for cardiometabolic disease (high blood lipids, hyperglycemia, insulin resistance, systemic inflammation, oxidative stress, obesity, elevated visceral fat, etc.). Thus, improvements in body composition and reductions in disease risk provides compelling evidence to pursue this study with vigor so as to generate a viable and healthy weight and fat loss strategy over the long term. Another major factor to augment long-term (\>1 year) weight loss success, is inclusion of a safe and realistic exercise program (4 days/week) consisting of walking, stretching, and simple body weight movements such as sit-ups and push-ups. To date, there are no documented case studies of a human participant achieving a one hundred pound plus weight loss using protein pacing and intermittent fasting combined with a proven, safe and time-efficient exercise program. The purpose of this study is to compare the effects of a low sugar protein pacing, intermittent fasting (P-IF) diet versus a heart healthy (HH) diet on indices of body weight, total and regional body composition, mood state, anti-aging, and cardiometabolic outcomes, and the gut microbiome during weight loss (0-8 weeks). Specifically, this study aims to compare a P-IF diet comprised of a calorie-restricted (1500 calories/day women; 1800 calories/day men) protein pacing diet (P, 4 meals/day women, 5 meals/day men) followed by a fast (IF, \ 350-450 kcals/day) compared to an established calorie-restricted (1200 calories/day for women; 1500 calories/day men) heart healthy (HH) diet. The P-IF group will be divided into two subgroups for weeks 1-4. One subgroup will consist of five days of P and two days of IF, and the second subgroup will consist of six days of P and one day of IF. For weeks 5-8 both subgroups will follow 6 days of a P diet and 1 day IF. The purpose of the additional 12 month follow up case study (in addition to the initial 12-month case study period) is to scientifically document a significant weight loss and improved body composition following combined protein pacing intermittent fasting nutrition and a safe, effective exercise program in a study participant who achieved successful weight loss maintenance during the previous 12 month follow up study period.
Interventions
BEHAVIORALP-IF
Protein pacing and intermittent fasting
BEHAVIORALHH
Heart Healthy
Sponsors
Arizona State University
Isagenix International LLC
Skidmore College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
40 overweight/obese adult men (n=20) and women (n=20) will be quasi-randomized to one of the two groups matched by sex (men/women) and body weight. Participants will be enrolled in the study as a single cohort and participate in a 8-week weight loss (WL) trial consisting of a single dietary intervention phase. A single male participant from the original P-IF group will continue following the identical P-IF from the original 4-8 week phase and 12 month follow up period (5-6 days of P; 1-2 day of IF) for an additional 12 month period (beyond the initial 12 monthfollow up case study period). The participant will consume the identical P-IF meal plan as the original 8 week study and 24 month follow up.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Non-smoking, healthy, but overweight/obese men and women with no known cardiovascular or metabolic diseases as assessed by a medical history and a comprehensive medical examination by their physicians * Sedentary or lightly active (\<30 min, 2d/wk of structured physical activity) as assessed by a Physical Activity questionnaire * Overweight or obese (BMI\>27.5 kg/m2; % body fat\>30%) * Weight stable (+/-2kg) for at least 6 months prior to beginning the study
Exclusion criteria
* Type II Diabetes * Emphysema * Significant heart disease (CABG, CHF, VFib, Hypercholesterolemia, Uncontrolled High Blood Pressure, etc.) * COPD * Cancer or undergoing treatment for cancer * Allergies to milk or milk products, sugar alcohols, fructose, or gluten * Anorexia or Bulimia * Fasting intolerances/hypoglycemia * Pregnant or plan to become pregnant during 8-week study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body weight | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | Total body weight measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in feelings of hunger, fullness, satiety scores measured with a visual analog scale | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | Hunger ratings using a visual analog scale ranging from 0-100 mm. A score closer to 0mm indicates no level of hunger related feelings and a score of 100 mm indicates extreme hunger-related feelings |
| Change in blood lipid levels | 0 weeks, 4 weeks, 8 weeks and every 6 months during the 2 year Case Study | Venipuncture blood draw of 5ml per visit (weeks 0 and 8) and a single finger stick\* of 40ul (week 4); \*Finger stick at week 4 will only measure glucose and blood lipids |
| Change in gut microbiome, gastrointestinal symptoms, stool | 0 weeks, 4 weeks, 8 weeks and two month intervals during the 2 year Case Study | Fecal gut microbiome communities will be sequenced using microbial DNA extracted from samples at 0, 4, and 8 weeks for each study arm. Amplified copies of the 16S rRNA gene will be evaluated for treatment differences in alpha (within-sample richness and evenness) and beta diversity (between-sample community structure). Relative and differential abundance of individual microbial taxa will also be measured. In addition, GI symptoms will be assessed using the Gastrointestinal symptom questionnaire and stool quality will be assessed with the Bristol stool chart |
| Change in blood pressure | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | Quantitative measure of blood pressure using automated blood pressure monitor called a mobiligraph for 1 minute |
| Change in total and regional body fat and lean body mass | 0 weeks, 8 weeks, 1 year and 2 year of the Case study | Quantitative measure of total body fat and lean mass using iDXA (dual x-ray absorptiometry) |
| Change in fat mass and muscle mass | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | Quantitative measure of total body fat and muscle mass using BODPod (air displacement plethysmography) |
| Change in physical activity | 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study | Quantitative measure of physical activity (kilocalories per day) using the ActiGraph accelerometer |
| Change in energy intake | 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study | Quantitative measure of energy intake (kilocalories per day) using the 2-day food diary |
| Change in heart rate | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | Quantitative measure of heart rate using automated heart rate monitor called a mobiligraph for 1 minute |
Countries
United States
Outcome results
None listed