{ "data": { "asOf": "2026-10-30T22:27:52.163Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT00687115", "title": "Predicting Weight Gain and Weight Loss Associated With Overeating or Fasting", "scientificTitle": "Predicting Adaptive Thermogenesis", "status": "completed", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Obesity", "Diet Therapy", "Weight Loss", "Weight Gain", "Nutrition Therapy" ], "interventions": [ { "name": "Weight Loss", "type": "BEHAVIORAL", "description": "liquid diet at 50% of weight maintaining intake" }, { "name": "Overfeeding", "type": "BEHAVIORAL", "description": "Overfeeding at 150% of weight maintaining intake" }, { "name": "Overfeeding Low Pro", "type": "BEHAVIORAL", "description": "Overfeeding 150% of normal intake at \\<5% protein" } ], "sponsor": { "name": "National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)", "type": "NIH" }, "locations": [ { "city": "Phoenix", "country": "United States", "facility": "NIDDK, Phoenix" } ], "outcomes": { "other": [], "primary": [ "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." ], "secondary": [ "Determine if hormones, responses to behavioral testing, adipocyte size, body composition, core temperature, spontaneous activity, and food absorption/excretion are related to changes in EE with over/under-feeding and variation in weight change." ] }, "eligibility": { "sex": "ALL", "criteria": "* INCLUSION CRITERIA:\n* BMI greater than or equal to 27 kg/m(2) for the weight loss protocol but body weight less than 350 pounds to accommodate the DXA scanner.\n* BMI less than or equal to 24 kg/m(2) (and BMI greater than or equal to 18.5 kg/m(2) for the overfeeding protocols. A history of low BMI and difficulty gaining weight.\n* Age 18-60 years, to minimize potential co-morbid conditions which may indirectly affect EE. Minors under the age of 18 will be excluded because growth and pubertal issues are significant parameters that could affect our outcomes and also because the time requirements of the study are such that they would interfere with school schedules. Women who are post-menopausal will be excluded from the study as changes in their metabolism could affect the baseline measurements which are hypothesized to predict weight change.\n* Healthy, as determined by medical history, physical examination, and laboratory tests\n\nEXCLUSION CRITERIA:\n\n* Current smoking\n* Type 2 diabetes (according to the World Health Organization diagnostic criteria)\n* Impaired glucose tolerance (according to the World Health Organization diagnostic criteria) for those participating in the overfeeding study arms only\n* Endocrine disorders (Cushing s Disease, pituitary disorders, and hypo- and hyperthyroidism)\n* Chronic pulmonary disorders, including chronic obstructive pulmonary disease that would limit ability to follow the protocol (investigator judgment) and obstructive sleep apnea syndrome; only subjects with mild or exercise-induced asthma on no medications or on beta-adrenergic agonists only (such as albuterol) will be allowed to enter the study (provided use of these agents is not required for one week before study entry).\n* Cardiovascular diseases (coronary heart disease, heart failure, arrhythmias, and peripheral artery disease)\n* Hypertension (blood pressure measurement higher than 140/90 mm Hg (overfeeding study) or 160/95 (weight loss study) on two or more occasions or use of anti-hypertensive medications)\n* Diagnosed gastrointestinal diseases, including inflammatory bowel diseases (e.g., Crohn s disease and ulcerative colitis), malabsorption syndromes (e.g., celiac disease), gastric ulcer (active); only subjects with gastro-esophageal reflux will be allowed to enter the study\n* Presence of a pacemaker or other implantable devices/shrapnel which may interfere with the MRI or CorTemp measurements\n* Liver disease (cirrhosis, active hepatitis B or C, and AST or ALT greater than or equal to 1.5 times normal)\n* Renal disease (serum creatinine concentrations greater than or equal to 1.5 mg/dl and/or overt proteinuria)\n* Central nervous system disease (cerebrovascular accidents, dementia, and neurodegenerative disorders)\n* Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer)\n* Alcohol (more than 3 drinks per day) and/or drug abuse (such as amphetamines, cocaine, heroin, or marijuana)\n* Current or past history of: bipolar disorder, schizophrenia or presence of psychotic symptoms, bulimia nervosa or anorexia nervosa, or current major depressive disorder\n* Pregnancy or lactation\n* Taking weight loss medications\n* Weight change of plus or minus 5% in the last 3 months\n\nConditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators. Additionally, potential subjects might be excluded if they demonstrate a style of interpersonal relationships that would inhibit successful completion of the study.", "maximumAge": "60 Years", "minimumAge": "18 Years", "healthyVolunteers": false }, "enrollment": { "type": "ACTUAL", "count": 83 }, "startDate": "2008-09-18", "completionDate": "2023-03-20", "lastUpdated": "2026-10-26T00:00:00.000Z", "firstPosted": "2008-05-30T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT00687115" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT00687115", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT00687115", "sourceUrl": "https://clinicaltrials.gov/study/NCT00687115", "sourceStatus": "COMPLETED", "retrievedAt": "2026-10-28T04:32:38.882Z", "payloadSha256": "d6a84734b28537c03f4a24639564f9eed1e06e0bef809eabd27ef5d97faa4ff3", "piiRedacted": true } ], "citation": { "canonicalId": "NCT00687115", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT00687115", "verifyAt": "https://clinicaltrials.gov/study/NCT00687115", "retrievedAt": "2026-10-28T04:32:38.882Z", "payloadSha256": "d6a84734b28537c03f4a24639564f9eed1e06e0bef809eabd27ef5d97faa4ff3", "text": "ClinicalTrials.gov, record NCT00687115 (https://clinicaltrials.gov/study/NCT00687115), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT00687115, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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