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NCT04812964 · ClinicalTrials.gov registry record · NA
Modulation of the Intestinal Microbiome by a High Protein Diet
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 106
- Enrollment target
NCT04812964: Completed NA study, sponsored by VA Office of Research and Development.
NCT04812964 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 106 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04812964, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
Study 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.
Primary Outcome
The primary objective is to compare weight loss between each of the two diets, a high-protein diet versus a standard protein diet.
Interventions
- DIETARY_SUPPLEMENT 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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2024-03-31 |
| Phase | NA |
What the finished NCT04812964 record still lists
NCT04812964 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass is the first listed.
NCT04812964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04812964 about?
NCT04812964 is a clinical study titled "Modulation of the Intestinal Microbiome by a High Protein Diet". 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...
What is the current status of trial NCT04812964?
This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2018-04-03. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT04812964?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT04812964?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04812964's enrollment target sits among peer trials
106 830th of 2000 higher than 1,167 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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