Adaptive Responses to Overfeeding and Weight

NCT03857048 | Unknown DMC

• 1 other identifier: 18-0091
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Fat oxidation as a correlate of weight regain as measured by room calorimetry

  Fat oxidation as a correlate of weight regain will be assessed in both reduced obese groups with room calorimetry on two occasions, once after 3 days of overfeeding and once after 3 days of an energy balanced diet.

  24 hour period on day 7 of two diet conditions - one overfed & one eucaloric condition; weeks 16 & 20

Secondary Outcomes (16)

• Body weight per scale

  Baseline, after 12 week weight loss intervention and 1 year after the end of second study condition

• Body Composition via DXA

  Baseline, after 12 week weight loss intervention and 1 year after the end of second study condition

• Change in substrate utilization as measured by room calorimetry

  24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and week 16 & 20 for reduced groups

• Change in nocturnal lipolysis as measured by use of stable isotope tracer

  24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced

• Change in total energy expenditure (TEE) as measured by room calorimetry

  24 hour period, on day 7 of two diet conditions - eucaloric and overfed; week 1 and 4 for controls and weeks 16 and 20 for reduced

Other Outcomes (1)

• Change in fitness as measured by indirect calorimetry

  30 minutes at baseline and 1 year following second diet condition; Reduced group will have an additional measurement at week 12 following weight loss period.

Study Arms (3)

Control

ACTIVE COMPARATOR

Persons with obesity who do not undergo weight loss will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.

Other: Overfeeding

Reduced obese + diet + exercise

EXPERIMENTAL

Persons with obesity randomized to a weight loss program consisting of caloric restriction, behavioral support, and supervised endurance exercise training. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.

Other: Weight Loss; Other: Exercise training; Other: Overfeeding

Reduced obese + diet group

ACTIVE COMPARATOR

Persons with obesity randomized to a weight loss program consisting of caloric restriction and behavioral support. Following weight loss persons in this group will participate in an inpatient assessment to measure metabolic responses to a 3 day eucaloric diet or a 3 day overfeeding challenge. Participants will be followed for 1 year after the metabolic studies to track longitudinal changes in body weight and other relevant health outcomes.

Other: Weight Loss; Other: Overfeeding

Interventions

Weight Loss OTHER

12-wk weight loss intervention using a meal replacement strategy (Health \& Nutrition Technology, Carmel, CA), with an 8-10% weight loss goal

Reduced obese + diet + exercise; Reduced obese + diet group

Exercise training OTHER

16-wk supervised endurance exercise training program

Reduced obese + diet + exercise

Overfeeding OTHER

3-day hypercaloric diet designed to overfeed by 40% above total daily energy requirements

Control; Reduced obese + diet + exercise; Reduced obese + diet group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Colorado, Boulder: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Daniel Bessesen, MD

  University of Colorado Anschutz Health and Wellness Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheila Steinke, MS

CONTACT

303.724.3304; sheila.steinke@cuanschutz.edu

Emilee Mickaliger, BS

CONTACT

emilee.mickaliger@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Persons with obesity will be randomized to receive weight loss with or without supervised exercise. Metabolic phenotyping studies will be performed in both groups in the weight reduced state and compared to a group of obese persons not undergoing weight loss. All participants will be followed for a period of 1 year following metabolic phenotyping to track longitudinal changes in weight and other relevant outcomes measures.

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: February 27, 2019
• Study Start: February 15, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)