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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Human Nutrition and Metabolism Laboratory
Saratoga Springs, New York, United States
Change in body weight
Total body weight measurement
Time frame: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study
Change in total and regional body fat and lean body mass
Quantitative measure of total body fat and lean mass using iDXA (dual x-ray absorptiometry)
Time frame: 0 weeks, 8 weeks, 1 year and 2 year of the Case study
Changes in feelings of hunger, fullness, satiety scores measured with a visual analog scale
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
Time frame: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study
Change in blood lipid levels
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
Time frame: 0 weeks, 4 weeks, 8 weeks and every 6 months during the 2 year Case Study
Change in gut microbiome, gastrointestinal symptoms, stool
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
Time frame: 0 weeks, 4 weeks, 8 weeks and two month intervals during the 2 year Case Study
Change in blood pressure
Quantitative measure of blood pressure using automated blood pressure monitor called a mobiligraph for 1 minute
Time frame: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study
Change in heart rate
Quantitative measure of heart rate using automated heart rate monitor called a mobiligraph for 1 minute
Time frame: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study
Change in fat mass and muscle mass
Quantitative measure of total body fat and muscle mass using BODPod (air displacement plethysmography)
Time frame: 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study
Change in physical activity
Quantitative measure of physical activity (kilocalories per day) using the ActiGraph accelerometer
Time frame: 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study
Change in energy intake
Quantitative measure of energy intake (kilocalories per day) using the 2-day food diary
Time frame: 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study
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