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NCT00687115 · ClinicalTrials.gov registry record · Phase 2

Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting

A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 2
Development phase
83
Enrollment target

NCT00687115: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00687115 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00687115, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 2
Development phase
83 participants
Enrollment target

Study Summary

This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone gains or loses weight. Healthy people between 18 and 60 years of age who have a body mass index (BMI) between 18.5 kg/m(2) and 24 kg/m(2) (for overfeeding study) or a BMI greater than 27 kg/m(2) with a body weight less than 350 pounds (weight loss study) may be eligible for this study. The study requires a 10-week admission to the NIH Clinical Center (2-week baseline, 6-week overfeeding/weight loss, 2-week post-weight change). Participants undergo the following tests and procedures during the hospital admission: * Medical history, physical examination and laboratory studies * Questionnaires to assess eating behavior, food preferences, body composition, and activity level * Body composition assessment (height, weight, waist circumference, and fat mass and muscle content through DXA and MRI scans) * Oral glucose tolerance test * Meal test to measure the response of certain hormones to food * Activity monitors to determine activity level * Metabolic chamber study to measure calories burned over 24 hours and monitor body temperature * Free-living energy use study to measure calories burned under normal home conditions over 7 days * Fat and muscle biopsies * Dietary intervention: Measurements of food intake and energy loss over a 6-week overfeeding (1.5 times the subject s normal food intake) or weight loss (one-half the subject s normal food intake) program Followup procedures after the inpatient stay: * Height and weight measurements at 6 months (overfeeding study participants) and monthly for the first year, at 3-month intervals for the second year, and then yearly for 3 more years (weight loss study participants) * Yearly visits (2-night inpatient stay) for all partici

Primary Outcome

Changes in energy expenditure, weight, and body energy stores measured via physical examinations, laboratory studies, questionnaires, body composition assessments, oral glucose tolerance tests, metabolic chamber studies, and free-living energy use studies

Interventions

  • BEHAVIORAL Overfeeding
  • BEHAVIORAL Weight Loss
  • BEHAVIORAL Overfeeding Low Pro

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2008-09-18
Est. Completion 2023-03-20
Phase Phase 2

What the finished NCT00687115 record still lists

NCT00687115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 3 interventions - of which Overfeeding is the first listed.

NCT00687115 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00687115 about?

NCT00687115 is a clinical study titled "Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting". This study will investigate how to better predict why some individuals gain or lose weight more easily than others. It will examine whether the increase in the amount of energy a body burns in 24 hours with overeating or the decrease over 24 hours with fasting can help determine how easily someone g...

What is the current status of trial NCT00687115?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2008-09-18. Estimated completion is 2023-03-20.

What interventions are being tested in trial NCT00687115?

The interventions under investigation include: Overfeeding (BEHAVIORAL), Weight Loss (BEHAVIORAL), Overfeeding Low Pro (BEHAVIORAL).

Who is sponsoring clinical trial NCT00687115?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00687115's enrollment target sits among peer trials

83 828th of 2000 higher than 1,171 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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Source: ClinicalTrials.gov NCT00687115, the US trial registry maintained by the National Library of Medicine. NCT00687115 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.