Weight Loss Clinical Trial
Official title:
Comparison of Protein Pacing, Intermittent Fast vs. Heart Healthy Diet on Body Weight and Composition, Cardiometabolic, Mood, and Gut Microbiome Health, in Overweight Men and Women During Weight Loss; 24 Months Follow-up Case Study of 100 Pound Weight Loss in a Male Study Participant
Verified date | April 2024 |
Source | Skidmore College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2024 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Human Nutrition and Metabolism Laboratory | Saratoga Springs | New York |
Lead Sponsor | Collaborator |
---|---|
Skidmore College | Arizona State University, Isagenix International LLC |
United States,
Arciero PJ, Edmonds R, He F, Ward E, Gumpricht E, Mohr A, Ormsbee MJ, Astrup A. Protein-Pacing Caloric-Restriction Enhances Body Composition Similarly in Obese Men and Women during Weight Loss and Sustains Efficacy during Long-Term Weight Maintenance. Nutrients. 2016 Jul 30;8(8):476. doi: 10.3390/nu8080476. — View Citation
He F, Zuo L, Ward E, Arciero PJ. Serum Polychlorinated Biphenyls Increase and Oxidative Stress Decreases with a Protein-Pacing Caloric Restriction Diet in Obese Men and Women. Int J Environ Res Public Health. 2017 Jan 10;14(1):59. doi: 10.3390/ijerph14010059. — View Citation
Zuo L, He F, Tinsley GM, Pannell BK, Ward E, Arciero PJ. Comparison of High-Protein, Intermittent Fasting Low-Calorie Diet and Heart Healthy Diet for Vascular Health of the Obese. Front Physiol. 2016 Aug 29;7:350. doi: 10.3389/fphys.2016.00350. eCollection 2016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in body weight | Total body weight measurement | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | |
Secondary | 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) | 0 weeks, 8 weeks, 1 year and 2 year of the Case study | |
Secondary | 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 | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | |
Secondary | 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 | 0 weeks, 4 weeks, 8 weeks and every 6 months during the 2 year Case Study | |
Secondary | 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 | 0 weeks, 4 weeks, 8 weeks and two month intervals during the 2 year Case Study | |
Secondary | Change in blood pressure | Quantitative measure of blood pressure using automated blood pressure monitor called a mobiligraph for 1 minute | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | |
Secondary | Change in heart rate | Quantitative measure of heart rate using automated heart rate monitor called a mobiligraph for 1 minute | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | |
Secondary | Change in fat mass and muscle mass | Quantitative measure of total body fat and muscle mass using BODPod (air displacement plethysmography) | 0 weeks, 4 weeks, 8 weeks and monthly intervals during the 2 year Case Study | |
Secondary | Change in physical activity | Quantitative measure of physical activity (kilocalories per day) using the ActiGraph accelerometer | 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study | |
Secondary | Change in energy intake | Quantitative measure of energy intake (kilocalories per day) using the 2-day food diary | 0 weeks, 4 weeks, 8 weeks, and monthly intervals during the 2 year of the Case study |
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