CALERIE Phase II Ancillary: Metabolic
Public ClinicalTrials.gov record NCT02695511. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
CALERIE Phase II Ancillary 2: Metabolic Adaptation After Two Years of Caloric Restriction in Non Obese Humans
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02695511
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 25 Years to 46 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2007
- Primary completion
- Jan 31, 2010
- Completion
- Jan 31, 2010
- Last update posted
- Feb 29, 2016
2007 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02695511, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 29, 2016 · Synced Sep 13, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02695511 live on ClinicalTrials.gov.