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NCT01987388 · ClinicalTrials.gov registry record · NA
Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges
A NA study of Healthy Volunteers, sponsored by USDA Beltsville Human Nutrition Research Center.
- Completed
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01987388: Completed NA study of Healthy Volunteers, sponsored by USDA Beltsville Human Nutrition Research Center.
NCT01987388 is a NA study of Healthy Volunteers that has completed, run by USDA Beltsville Human Nutrition Research Center. The registered enrollment target is 16 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01987388, a NA study of Healthy Volunteers, has completed, sponsored by USDA Beltsville Human Nutrition Research Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective is to develop a new metabolic flexibility biomarker, which has application in the study of changes diet and exercise on fuel management in humans. The new biomarker involves the characterization of an individual's metabolic flexibility utilizing room calorimeters rather than the current method, which is based on glucose clamp data. It is hypothesized that this new metabolic flexibility method will be a useful and noninvasive biomarker for measuring adaptation to exercise and diet challenges.
Primary Outcome
Participants will stay in a room calorimeter for 24 hours where oxygen consumed and carbon dioxide produced will be measured. Mathematical approaches will use continuous calorimetry data to generate consistent estimates of the gas exchange rates, and hence accurate "instantaneous" respiratory exchange ratios. This novel approach allows evaluating the instantaneous dynamics of respiratory quotient noninvasively and for many different conditions (e.g., exercise and various nutrient ratios).
Conditions Studied
Interventions
- OTHER High Intensity Exercise
- OTHER Low Intensity Exercise
- OTHER High Carbohydrate Beverage
- OTHER High Fat Beverage
Study Locations (1)
Maryland
- USDA Beltsville Human Nutrition Center - Beltsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-12 |
| Est. Completion | 2013-09 |
| Phase | NA |
What the finished NCT01987388 record still lists
NCT01987388 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 4 interventions - of which High Intensity Exercise is the first listed.
NCT01987388 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01987388 about?
NCT01987388 is a clinical study titled "Metabolic Flexibility as a Biomarker of Adaptation to Diet and Exercise Challenges". The objective is to develop a new metabolic flexibility biomarker, which has application in the study of changes diet and exercise on fuel management in humans. The new biomarker involves the characterization of an individual's metabolic flexibility utilizing room calorimeters rather than the curren...
What is the current status of trial NCT01987388?
This trial is currently completed. It is a NA study. The enrollment target is 16 participants. The study started on 2012-12. Estimated completion is 2013-09.
What conditions does trial NCT01987388 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT01987388?
The interventions under investigation include: High Intensity Exercise (OTHER), Low Intensity Exercise (OTHER), High Carbohydrate Beverage (OTHER), High Fat Beverage (OTHER).
Who is sponsoring clinical trial NCT01987388?
This trial is sponsored by USDA Beltsville Human Nutrition Research Center, which has 29 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01987388 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01987388's enrollment target sits among peer trials
16 235th of 283 higher than 42 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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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