Status:
COMPLETED
Modulation of the Intestinal Microbiome by a High Protein Diet
Lead Sponsor:
VA Office of Research and Development
Conditions:
Obesity
Eligibility:
All Genders
20-60 years
Phase:
NA
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 in...
Detailed Description
A high protein diet has been shown in preclinical rodent models and clinical trials to be an effective obesity treatment that is associated with greater loss of body weight and fat mass and increased ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04812964
Start Date
April 3 2018
End Date
March 31 2024
Last Update
August 7 2024
Active Locations (1)
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1
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003