Modulation of the Intestinal Microbiome by a High Protein Diet

NCT04812964 | Completed Results

• 1 other identifier: GAST-030-17S
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Obesity

Keywords

Obesity; Microbiome; High protein diet

Outcome Measures

Primary Outcomes (1)

• Weight Loss (% Change) in Response to Dietary Intervention Change

  The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard protein diet.

  Primary outcome of weight loss is measured by subtracting the baseline weight on Day 1 from the weight at the end of the 16 week study period for each subject, and converting to % of baseline weight.

Secondary Outcomes (2)

• Change in Steatosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention

  Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.

• Change in Liver Fibrosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention

  Changes in liver steatosis will be measured at baseline and at the end of the 16 week study period for each subject.

Study Arms (2)

Standard Diet

ACTIVE COMPARATOR

Standard protein diet group as control based on 0.5 gram protein per pound of lean body mass with same calories: 15% protein and 55% carbohydrate.

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

High Protein Diet

ACTIVE COMPARATOR

High protein diet group based on 1 gram of protein per pound of lean body mass: 30% protein and 40% 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

Interventions

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

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.

Also known as: Standard Protein Diet

Standard Diet

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

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.

Also known as: High Protein Diet

High Protein Diet

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between 20 and 60 years of age,
• BMI 27 to 40 kg/m\^2,
• non-smoker or stable smoking habits for at least 6 months prior to screening and agreement not to change such habits during the study;
• subjects on non-obesity prescription medication may be included.

You may not qualify if:

• Weight change of \>3.0 kg in the month prior to screening, weight loss of \>10 kg in the 6 months prior to screening,
• calorie restriction diet (\<1500 kcal/day) for a period of 4 months or more in the 12 months prior to screening,
• use of any other investigational drug(s) within 8 weeks prior to screening,
• abnormal baseline laboratory parameters (serum creatinine \> 1.6 mg/dl; ALT, AST, total bilirubin \> 2.0 times the upper limit of normal;
• triglycerides \> 500 mg/dl, total cholesterol \> 350 mg/dl, TSH outside of normal range),
• consumption of more than 1 alcoholic beverage per day, pregnancy or intention to become pregnant.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

Location

Related Publications (3)

• Vu JP, Luong L, Parsons WF, Oh S, Sanford D, Gabalski A, Lighton JR, Pisegna JR, Germano PM. Long-Term Intake of a High-Protein Diet Affects Body Phenotype, Metabolism, and Plasma Hormones in Mice. J Nutr. 2017 Dec;147(12):2243-2251. doi: 10.3945/jn.117.257873. Epub 2017 Oct 25.

  PMID: 29070713 BACKGROUND

• Dong TS, Luu K, Lagishetty V, Sedighian F, Woo SL, Dreskin BW, Katzka W, Chang C, Zhou Y, Arias-Jayo N, Yang J, Ahdoot A, Li Z, Pisegna JR, Jacobs JP. A High Protein Calorie Restriction Diet Alters the Gut Microbiome in Obesity. Nutrients. 2020 Oct 21;12(10):3221. doi: 10.3390/nu12103221.

  PMID: 33096810 BACKGROUND

• Stengel A, Goebel-Stengel M, Wang L, Hu E, Karasawa H, Pisegna JR, Tache Y. High-protein diet selectively reduces fat mass and improves glucose tolerance in Western-type diet-induced obese rats. Am J Physiol Regul Integr Comp Physiol. 2013 Sep 15;305(6):R582-91. doi: 10.1152/ajpregu.00598.2012. Epub 2013 Jul 24.

  PMID: 23883680 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Proteins; Carbohydrates; Diet, High-Protein

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Jonathan Jacobs
• Organization: VA Greater Los Angeles Healthcare System

jonathan.jacobs2@va.gov

310-478-3711

Study Officials

• Jonathan P Jacobs, MD PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 24, 2021
• Study Start: April 3, 2018
• Primary Completion: July 19, 2023
• Study Completion: March 31, 2024
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)