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NCT02695511 · ClinicalTrials.gov registry record · Phase 2
CALERIE Phase II Ancillary: Metabolic
A Phase 2 study, sponsored by Pennington Biomedical Research Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT02695511: Completed Phase 2 study, sponsored by Pennington Biomedical Research Center.
NCT02695511 is a Phase 2 study that has completed, run by Pennington Biomedical Research Center. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02695511, a Phase 2 study, has completed, sponsored by Pennington Biomedical Research Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and sleeping) will be measured in a respiratory chamber. Other measures include the activities of the sympathetic nervous and thyroid axes, oxidative stress in lipids, protein and DNA, organ size by MRI and echocardiography, and posture allocation (time spent engaging in different activities and the energy expended during these activities), and activity temperament (the innate predilection for movement). This set of studies will allow assessment of whether the previously observed metabolic adaptation in response to 25% caloric restriction is long lasting (up to two years), associated with reduced thyroid and sympathetic activities and reduced oxidative damage. The studies of organ sizes (liver, spleen, kidney, heart, adipose and muscle) by MRI and echo (heart) is essential to determine whether the metabolic adaptation is related to decreased organ sizes or improved organ energy metabolism efficiency. The above described measures will be performed at baseline and after 1 and 2 years of a 25% caloric restriction in 50 non-obese humans and in 25 sex-, BMI- and age- matched subjects who will not engage in caloric restriction.
Primary Outcome
Measured via Respiratory Chamber
Interventions
- OTHER Caloric restriction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
What the finished NCT02695511 record still lists
NCT02695511 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 1 intervention - of which Caloric restriction is the first listed.
NCT02695511 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02695511 about?
NCT02695511 is a clinical study titled "CALERIE Phase II Ancillary: Metabolic". The primary aim of this NIA sponsored ancillary study of phase 2 CALERIE is to measure whether metabolic adaptation lasts up to 2 years in response to a 25% calorie restriction in normal-weight and slightly overweight individuals. Energy metabolism (24-hour sedentary and sleeping) will be measured i...
What is the current status of trial NCT02695511?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2007-05. Estimated completion is 2010-02.
What interventions are being tested in trial NCT02695511?
The interventions under investigation include: Caloric restriction (OTHER).
Who is sponsoring clinical trial NCT02695511?
This trial is sponsored by Pennington Biomedical Research Center, which has 258 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02695511's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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