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Obesity · Observational Study
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a completed observational registry record from the NIH Clinical Research Unit examining how metabolism responds to overfeeding and fasting across different diet compositions. No results are posted in this registry entry; the record describes study design, procedures, and planned follow-up through 7 years but contains no outcome data or clinical findings.
Observational. Obesity; age from 18 Years; to 55 Years. Intervention: Healthy Volunteers with normal glucose regulation. Compared with: Weight-maintenance diet and fasting (within-participant comparison). n = 203. 1 site: United States.
This is a completed observational registry record from the NIH Clinical Research Unit examining how metabolism responds to overfeeding and fasting across different diet compositions. No results are posted in this registry entry; the record describes study design, procedures, and planned follow-up through 7 years but contains no outcome data or clinical findings.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This registration record cannot guide clinical practice because no results are reported. Once results are published, findings on individual metabolic responses to overfeeding and fasting may inform understanding of weight gain resistance and energy balance mechanisms.
This is a completed observational study registration with no results posted; it describes the planned design and procedures but contains no outcome data, effect sizes, or clinical findings to evaluate.
As stated by the source record.
Quoted from the source exactly as published.
This registration record cannot guide clinical practice because no results are reported. Once results are published, findings on individual metabolic responses to overfeeding and fasting may inform understanding of weight gain resistance and energy balance mechanisms.
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 (NCT00523627). This is a study registration, not published results. Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 203 participants (ACTUAL). Conditions: Obesity. Primary outcome measures: Weight, DXA scans, resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature , at baseline visit, 6 month visit, and then annually for up to 7 years; Weight, DXA scans , at baseline visit, 6 month visit, and then annually for up to 7 years; Resting metabolic rate, thermic effect of food, energy cost of physical activity, cycle ergometry, core body and distal skin temperature , at baseline visit, 6 month visit, and then annually for up to 7 years. Brief summary: This study, conducted at the NIH Clinical Research Unit at the Phoenix Indian Medical Center, will examine how the body s metabolism (energy expenditure) changes when people overeat and when they fast and how different diets (e.g., high-protein or high-fat) affect metabolism. The results may provide information about whether there are mechanisms that make some people more resistant than others to gaining weight when they eat more. Non-smoking healthy subjects between 18 and 55 years of age who weigh no more than 350 pounds may be eligible for this study. Participants undergo the following procedures: * Pregnancy test for women of childbearing age. * Oral glucose tolerance test. For this test, an I.V. line (needle attached to a plastic tube) is inserted into a vein to allow several blood draws without repeated needle sticks. After the first blood sample is drawn, the subject drinks a cola-flavored sugar solution. Five additional blood samples are then drawn over 3 hours. * Blood test for DNA (genetic) studies related to obesity, diabetes and related medical problems. * DEXA scan. This test measures body fat. The subject lies on a table while a very small dose of X-rays is passed through the body. * Respiratory chamber. This test measures how many calories the body burns a day and assesses energy balance between intake and expenditure. Subjects stay in a room with two windows, equipped with a sink, toilet, television and DVD player, desk, chair, telephone and bed for 24 hours. The test is repeated five times during the first 18-day admission and 3 times during the second 13-day admission. For the first two sessions, subjects are fed a diet equal to the amount of energy their body uses. For the next 6 stays they are fed double the amount of calories their body usually uses for 5 of the stays and fast (consume nothing but water and soda without caffeine or calories) during 1 stay. The overfeeding diets may be high or low in protein, normal in protein, or high in fat. Blood tests are done on the day of each respiratory chamber session and a 24-hour urine sample is collected for one day while in the chamber. * Eating behavior questionnaires. * Psychological performance tests. Some participants are asked to volunteer to repeat two of the chamber studies to validate the measurements. The repeat session includes only the fasting and the overfeeding with normal protein content. All participants are followed at 6 months with blood tests, a DEXA scan, and urine tests (including pregnancy test for women). At annual visits for years 1 through 7, participants have the 6-month tests plus an oral glucose tolerance test. ...
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