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

NCT04327141 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-08

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

P-IF

Protein pacing and intermittent fasting

BEHAVIORAL

HH

Heart Healthy

Sponsors & Collaborators

  • Arizona State University

    collaborator OTHER

  • Isagenix International LLC

    collaborator INDUSTRY

  • Skidmore College

    lead OTHER

Principal Investigators

  • Paul J Arciero, PhD · Skidmore College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2023-04-01
Completion
2024-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327141 on ClinicalTrials.gov