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NCT02525419 · ClinicalTrials.gov registry record · NA
Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women
A NA study of Weight Loss, sponsored by Skidmore College.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT02525419: Completed NA study of Weight Loss, sponsored by Skidmore College.
NCT02525419 is a NA study of Weight Loss that has completed, run by Skidmore College. The registered enrollment target is 43 participants, below the 1,501-participant average among 116 other Weight Loss 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
NCT02525419, a NA study of Weight Loss, has completed, sponsored by Skidmore College.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This study systematically quantified the effects of intermittent fasting and caloric restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate utilization in 43 overweight/obese middle-aged men (n=22) and women (n=21). Participants were enrolled in the study as a single cohort and participated in an 12-week trial consisting of two consecutive phases: 1) 1-week baseline, weight maintenance control phase (C), and 2) 11-week weight loss IFCR phase. During the 1 week C phase, volunteers were required to maintain their body weight by consuming their normal food intake; however, during the 11 week IFCR, subjects were instructed to consume 75% of their normal intake to result in a 1-2 lb of body weight loss per week. At the conclusion of the 12 week weight loss study, all 40 participants (3 drop-outs) were invited to enroll in a 12 month follow up study. If they agreed to participate, groups were balanced so there were similar numbers of men and women and were weight-matched. The two groups (n=37, 3 dropped prior to allocation) included: 1) a modified version of the 12 week weight loss intervention that consumes whole foods along with 2 meal replacements (rather than 3) (MR; n=19) or 2) a whole foods diet similar to the Therapeutic Lifestyle Changes diet recommended by the National Institute of Health (TLC, n= 18) and asked to follow these nutritional guidelines ad libitum for the duration of 12 months.
Primary Outcome
Quantitative measure of total body fat using the iDXA (dual x-ray absorptiometry)
Conditions Studied
Interventions
- BEHAVIORAL HH
- BEHAVIORAL Weight Loss Phase
- BEHAVIORAL HP-IF
Study Locations (1)
New York
- Human Nutrition and Metabolism Laboratory - Saratoga Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2013-08 |
| Est. Completion | 2015-03 |
| Phase | NA |
What the finished NCT02525419 record still lists
NCT02525419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 1,501-participant average among 116 other Weight Loss trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Weight Loss appearing as the primary indexed condition, and to 3 interventions - of which HH is the first listed.
NCT02525419 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT02525419 about?
NCT02525419 is a clinical study titled "Intermittent Fasting, Caloric Restriction and Body Composition in Obese Men and Women". This study systematically quantified the effects of intermittent fasting and caloric restriction (IFCR) on total and regional (abdominal) body composition (lean mass and fat mass), blood lipids, toxins, oxidative stress biomarkers, energy expenditure, and substrate utilization in 43 overweight/obese...
What is the current status of trial NCT02525419?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2013-08. Estimated completion is 2015-03.
What conditions does trial NCT02525419 study?
This clinical trial studies the following conditions: Weight Loss.
What interventions are being tested in trial NCT02525419?
The interventions under investigation include: HH (BEHAVIORAL), Weight Loss Phase (BEHAVIORAL), HP-IF (BEHAVIORAL).
Who is sponsoring clinical trial NCT02525419?
This trial is sponsored by Skidmore College, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02525419 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 NCT02525419's enrollment target sits among peer trials
43 84th of 116 higher than 33 of 116 other Weight Loss trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Weight Loss 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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