CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 106 enrolled
Drug / intervention
Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04812964
NCT04812964N/ACompleted
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Modulation of the Intestinal Microbiome in Obesity by a High Protein Diet

VA Office of Research and Development·interventional·Posted Mar 24, 2021·Updated Aug 7, 2024

In Brief

A clinical study evaluating Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass and Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate for Obesity. Completed, enrolled 106 participants across 1 site.

Detailed Summary

The objective of this study is to test and determine whether a high protein diet induces weight loss by modulating the composition and function of the intestinal microbiome in obesity. This will be investigated in a randomized clinical study comparing the effect of isocaloric high and normal protein diets on the intestinal microbiome composition, gene content, and metabolome of obese subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 24, 2021
Enrollment StartApr 3, 2018
Primary CompletionJul 19, 2023
Study CompletionMar 31, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 5.3 years ago

Interventions

Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body massdietary

Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.

Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydratedietary

High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.