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Overfeeding Low Pro / Obesity / Weight Loss · Phase 2 Trial
ClinicalTrials.gov · August 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed Phase 2 registry record documenting a 10-week inpatient study designed to investigate whether acute changes in energy expenditure during overfeeding or fasting predict subsequent weight change. No results are posted in this registry entry, and the evidence base remains pending publication of outcomes.
Phase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Obesity, Diet Therapy, Weight Loss, Weight Gain, Nutrition Therapy; age from 18 Years; to 60 Years. Intervention: Overfeeding; Weight Loss. n = 83. 1 site: United States.
This is a completed Phase 2 registry record documenting a 10-week inpatient study designed to investigate whether acute changes in energy expenditure during overfeeding or fasting predict subsequent weight change. No results are posted in this registry entry, and the evidence base remains pending publication of outcomes.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This registry record documents a study design only; no clinical impact can be inferred until results are published. The study aims to improve prediction of individual weight response to dietary change, but outcomes remain unreported.
This is a completed Phase 2 interventional study registration with no results reported; the registry record describes planned design and procedures only, making it a preliminary phase study awaiting outcome data.
As stated by the source record.
Quoted from the source exactly as published.
This registry record documents a study design only; no clinical impact can be inferred until results are published. The study aims to improve prediction of individual weight response to dietary change, but outcomes remain unreported.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT00687115). This is a study registration, not published results. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 83 participants (ACTUAL). Conditions: Obesity, Diet Therapy, Weight Loss, Weight Gain, Nutrition Therapy. Interventions: BEHAVIORAL: Weight Loss; BEHAVIORAL: Overfeeding; BEHAVIORAL: Overfeeding Low Pro. Primary outcome measures: The primary goal of the current study is to determine if changes in energy expenditure in response to acute over- and underfeeding are related to variation in changes in weight and body energy stores with longer-term over- and underfeeding. , Ongoing. Brief 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 participants for repeat meal test, DXA, oral glucose tolerance test, behavioral questionnaires and, in women who can become pregnant, pregnancy test
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