Recruiting

Obesity Research

Sponsor:

Concordia University, Montreal

Code:

NCT07515547

Conditions

Obesity & Overweight

Metabolism Changes

Lipid Metabolism

Eligibility Criteria

Sex: All

Age: 25 - 40

Healthy Volunteers: Not accepted

Interventions

Weight loss

Study Details

Brief summary:

The goal of this study is to understand if there are differences in the fat, muscle and metabolism of individuals who developed obesity during childhood versus those who developed obesity in adulthood. We will do this by having recruited participants undergo subcutaneous adipose tissue biopsies in the abdomen and thigh, a muscle biopsy in the thigh, collect blood and urine samples, a DEXA scan and 3 submaximal exercise tests. participants will also have their resting energy expenditure measured through indirect calorimetry to tailor a targeted weight loss protocol through caloric restriction and cardiovascular exercise (3 times a week). After 10% of weight loss is completed, study participants will repeat all tests during a 2 week weight stabilization period. At 12 weeks into the intervention, indirect calorimetry, DEXA scan and blood tests will be repeated.

Conditions

Obesity & Overweight

Metabolism Changes

Lipid Metabolism

Study ID

NCT07515547

Start date

Apr 30, 2025

Status verified date

Apr, 2025

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria:

We are recruiting two groups of sedentary or untrained males and pre-menopausal females (age 25-40 years) with body mass indices (BMI) between 30.0-39.9 kg/m\^2. All participants will be required to provide a medical record and/or photographic evidence of weight at childhood (around age of 10-17 years old). Individuals with BMI between 40.0-41.9 may be included in the case that an individual with a much shorter height falls within this range, as BMI does not always properly define obesity type. Once the participant completes their DEXA scan, we will be able to more accurately assess the participant's obesity level and re-evaluate their elgibility.

Exclusion criteria:

Participants will be excluded if they are pregnant or planning to become pregnant, breast-feeding, presently using nicotine containing products (e.g. cigarettes, chewing tobacco, nicotine gum etc.), taking certain anti-depressants and anti-hypertensives. More modern medications will not need to be excluded as they don't affect weight loss or weight gain. As medication use will be screened, if the participant is using medications that do not affect our outcomes they will be included in the study. Participants will also be excluded if they have had any surgery (e.g. gastric bypass, magnetic implants) or have any conditions (e.g. iron deficiency anemia) or diseases (e.g. diabetes, cancer, IBD, history of eating disorders or mental illness) that may affect immune function and thus study outcomes, or the ability to participate in the study.

Participants must also have been weight stable for at least 2 months.

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Childhood-onset obesity

Individuals who developed severe overweight or obesity during childhood (before puberty)

Adult-onset obesity

Individuals who developed obesity as adults

Interventions

Weight loss

A conventional weight loss program will be implemented for participants to lose approximately 10% of their starting body weight

Primary outcome measure

  • Immune cell quantification [ Time Frame: 4 years ]
  • Pre-adipocyte and adipocyte characteristics [ Time Frame: 5 years ]
  • Muscle and adipose tissue interaction [ Time Frame: 5 years ]
  • Blood inflammatory markers [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Sylvia Santosa, R.D, Ph.D

514-848-2424s.santosa@concordia.ca

Locations

Concordia University PERFORM Centre

Recruiting

Montreal, Quebec, Canada, H4B 1R6

Contacts

Concordia University PERFORM Centre

Recruiting

Montreal, Quebec, Canada

Contacts

More Information

Sponsor

Concordia University, Montreal

Last update posted

Apr 7, 2026

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Concordia University, Montreal on 2026-04-07.