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NCT00683826 · ClinicalTrials.gov registry record · NA
The Effects of Leucine on Body Weight
A NA study of Obesity and Overweight, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT00683826: Completed NA study of Obesity and Overweight, sponsored by Columbia University.
NCT00683826 is a NA study of Obesity and Overweight that has completed, run by Columbia University. The registered enrollment target is 8 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00683826, a NA study of Obesity and Overweight, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Protein-rich diets appear to show some benefits in promoting weight loss. It is thought that increased intake of leucine may account for some of this effect. This study is designed to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply to humans. Specifically, our team would like to determine whether oral leucine supplementation in overweight/obese humans increases metabolic rate, reduces body weight, improves glucose utilization and/or, reduces circulating fat levels in the blood. We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This study will should provide data that can be used to design more definitive trials with regard to dietary leucine supplementation. Hypothesis This pilot study is designed to accomplish the following two goals: 1. to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply in humans. Specifically, we want to determine whether oral leucine supplementation in overweight/obese individuals' increases basal metabolic rate, reduces body weight, improves glucose tolerance and/or insulin sensitivity, and/or reduces circulating Low-density Lipoprotein (LDL)-cholesterol levels. 2. To provide data that can be used to design more definitive trials with regard to dietary leucine supplementation. We hope that the results obtained from this pilot study will highlight the specific aspects of metabolic improvement associated with increased daily leucine intake. This would in turn lead to more rigorous clinical trials involving larger sample sizes, and with diverse populations of different gender, age, and ethnic groups. Future trials may also be directed to determine minimal doses and durations of leucine supplementation that are capable of achieving clinically significant improvement in the cardio-metabolic risk profile in people.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT L-Leucine 8gr
- OTHER Liquid meal
- DIETARY_SUPPLEMENT L-Leucine 4g
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-02 |
| Phase | NA |
What the finished NCT00683826 record still lists
NCT00683826 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 3 interventions - of which L-Leucine 8gr is the first listed.
NCT00683826 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00683826 about?
NCT00683826 is a clinical study titled "The Effects of Leucine on Body Weight". Protein-rich diets appear to show some benefits in promoting weight loss. It is thought that increased intake of leucine may account for some of this effect. This study is designed to assess whether any of the beneficial effects of dietary leucine supplementation observed in mice also apply to human...
What is the current status of trial NCT00683826?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2007-05. Estimated completion is 2010-02.
What conditions does trial NCT00683826 study?
This clinical trial studies the following conditions: Obesity, Overweight.
What interventions are being tested in trial NCT00683826?
The interventions under investigation include: L-Leucine 8gr (DIETARY_SUPPLEMENT), Liquid meal (OTHER), L-Leucine 4g (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00683826?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00683826 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00683826's enrollment target sits among peer trials
8 1038th of 1053 higher than 10 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity 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.
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