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Modulation of the Intestinal Microbiome by a High Protein Diet

NCT04812964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-08-07

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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

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.

DIETARY_SUPPLEMENT

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

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jonathan P Jacobs, MD PhD · VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2023-07-19
Completion
2024-03-31

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 NCT04812964 on ClinicalTrials.gov