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ACTIVE NOT RECRUITING
NCT04327141
NA

Low Sugar Protein Pacing, Intermittent Fasting Diet in Men and Women

Sponsor: Skidmore College

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

25 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-09-03

Completion Date

2024-12-31

Last Updated

2024-04-08

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

P-IF

Protein pacing and intermittent fasting

BEHAVIORAL

HH

Heart Healthy

Locations (1)

Human Nutrition and Metabolism Laboratory

Saratoga Springs, New York, United States