Status:
ACTIVE_NOT_RECRUITING
Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women
Lead Sponsor:
Skidmore College
Collaborating Sponsors:
Arizona State University
Isagenix International LLC
Conditions:
Weight Loss
Gut Microbiome
Eligibility:
All Genders
25-65 years
Phase:
NA
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 lip...
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 com...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04327141
Start Date
September 3 2020
End Date
December 31 2024
Last Update
April 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Human Nutrition and Metabolism Laboratory
Saratoga Springs, New York, United States, 12866