Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women
Status unconfirmed · Not applicable
Conditions studied: Weight Loss, Gut Microbiome, Anti-Aging
In brief
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.
Key facts
- Study ID
- NCT04327141
- Run by
- Skidmore College
- People needed
- 40
- Starts
- 2020-09-03
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2024-04-08
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Human Nutrition and Metabolism Laboratory — Saratoga Springs, New York, United States
Full record on ClinicalTrials.gov
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