Adaptive Responses to Overfeeding and Weight
To more effectively address the problem of weight regain following weight loss for obese individuals, this study will evaluate the underlying biology of the reduced obese state. In depth studies of appetite, energy expenditure, physical activity levels and fat metabolism will be completed in obese and reduced obese individuals; with the latter subdivided into those who have lost weight with diet alone or diet plus exercise. Individuals will be studied following a brief overfeeding period to better understand how differences in biological responses to overeating might be involved in promoting or protecting against weight gain.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 15 February 2019
🗓️ Primary Completion (Estimated) 1 January 2024
✅ Study Completion (Estimated) 1 January 2024
👥 Enrollment (Estimated) 75
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Aurora, Colorado, United States

📋 Eligibility Criteria

Description

  • Inclusion criteria.
  • * BMI of 30-38 kg/m2 and weight stable over the previous 6 months.
  • * Satisfied with current weight and not planning to lose weight at the time of enrollment (persons with obesity control group) -or- not satisfied with current weight and motivated to lose weight at the time of enrollment (reduced obese groups)
  • * No more than 90 min or 3 bouts of planned physical activity/wk.
  • * Pass a medical and physical screening performed by the study physician.
  • * Reporting a habitual, regular sleep-wake cycle for the month preceding screening that involved going to bed between 2200 and 0100 h and getting up between 0600 and 0900 h with \>7 h and \<9.25 h in bed.
  • * Live or work within 45 minutes of the CU-AMC (reduced obese groups only) (exceptions may be made at the discretion of the Study PI on a case by case basis for highly motivated subjects).
  • * Own a smartphone (Android or Apple iOS).
  • * For Females
  • * Not currently pregnant or lactating
  • * Not pregnant within the past 6 months
  • * Not planning to become pregnant in the next 12 months; sexually active women of childbearing potential may be enrolled if they use a reliable means of contraception
  • * Capable and willing to provide informed consent, understand exclusion criteria, and accept the randomized group assignment (reduced obese groups)
  • Exclusion criteria.
  • * Being considered unsafe to participate as determined by the study physician;
  • * Taking medications affecting weight, triglycerides, or energy intake/energy expenditure in the last 3 months;
  • * Having abnormal blood chemistry and/or hematology as deemed significant by the study physician;
  • * Ever having a history of systemic, psychiatric, neurological disease, or drug and alcohol abuse;
  • * History of cardiovascular disease, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases, dyslipidemia or any other medical condition affecting weight or lipid metabolism;
  • * Score \> 18 on Beck Depression Index (BDI) will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
  • * Use of a continuous positive airway pressure (CPAP) device for the treatment of obstructive sleep apnea (OSA). A score of \>10 on the Epworth sleepiness scale or \>5 on the Pittsburgh Sleep Quality Index will require further assessment by the study physician to determine if it is appropriate for the subject to participate in the study;
  • * Being positive for human immunodeficiency virus or hepatitis B or C;
  • * History of surgical procedure for weight loss at any time (e.g. gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve);
  • * Being a smoker or having been a smoker in the previous 6 months;
  • * Abnormal eating patterns identified by registered dietitian interview (dietary fat\<15%, dietary fat\>45%, dietary protein \>30%);
  • * Working night shifts;
  • * Night eating syndrome (at least 25% of food intake is consumed after the evening meal and/or at least two episodes of nocturnal eating per week);
  • * Traveling \> 2 time zones 2 weeks prior to an inpatient CTRC study visit;
  • * Currently participating in any formal weight loss or physical activity programs or clinical trials.
Ages Eligible for Study: 30 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 22 October 2018
  • First Submitted that Met QC Criteria 25 February 2019
  • First Posted 27 February 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 April 2023
  • Last Update Posted 7 April 2023
  • Last Verified April 2023