NCT04812964Completed
Modulation of the Intestinal Microbiome by a High Protein Diet
Modulation of the Intestinal Microbiome in Obesity by a High Protein Diet
Source: ClinicalTrials.gov · Last updated 7 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 11 Mar 2021
- Start date
- 3 Apr 2018
- Primary completion date
- 19 Jul 2023
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Obesity
- NCT number
- NCT04812964
What you commit to
- Study type: Interventional
- Participants enrolled: 106
- From 3 Apr 2018 to the primary completion date, 19 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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,
Lab values
- 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),
Other
- consumption of more than 1 alcoholic beverage per day, pregnancy or intention to become pregnant.
Who the study is looking for
- 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.
Age in the registry: 20 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA Coordinator of this site? Confirm its status | West Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.