N/A
N=87
Modulation of the Intestinal Microbiome by a High Protein Diet
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04812964 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Weight Loss (% Change) in Response to Dietary Intervention Change — -3.83; -3.89 percentage weight change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass (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 (Dietary_supplement)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss (% Change) in Response to Dietary Intervention Change |
-3.83; -3.89 | — |
| SECONDARY Change in Steatosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention |
-18.3; 3.5 | — |
| SECONDARY Change in Liver Fibrosis From Baseline as Measured by Fibroscan in Response to Dietary Intervention |
-1.77; -0.07 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 ( 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.
Data sourced from ClinicalTrials.gov (NCT04812964). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.