How body fat, muscle, and metabolism differ after childhood versus adult-onset obesity
Acute and Chronic Effects of Obesity
This study will test whether adults who became obese as children have different fat, muscle, and metabolism features than adults who became obese later, using biopsies, scans, exercise tests, and a targeted weight-loss program.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 25 Years to 40 Years |
| Sex | All |
| Sponsor | Concordia University, Montreal Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT07515547 on ClinicalTrials.gov |
What this trial studies
Researchers will enroll sedentary or untrained men and pre-menopausal women aged 25–40 with BMI roughly 30.0–39.9 kg/m2 and require proof of childhood weight history. Participants will undergo abdominal and thigh subcutaneous fat biopsies, a thigh muscle biopsy, blood and urine collection, DEXA body-composition scanning, three submaximal exercise tests, and resting energy expenditure measurement by indirect calorimetry. A personalized weight-loss program combining caloric restriction and cardiovascular exercise three times per week will be used until participants lose 10% of body weight, followed by a two-week weight stabilization period during which baseline tests are repeated. At 12 weeks into the intervention, key measures including indirect calorimetry, DEXA, and blood tests will be repeated to compare acute and chronic tissue and metabolic responses by age-of-onset group.
Who should consider this trial
Good fit: Ideal participants are sedentary or untrained men and pre-menopausal women aged 25–40 with BMI about 30.0–39.9 kg/m2 who can provide medical record or photographic evidence of their weight during childhood (around ages 10–17).
Not a fit: People who are pregnant or planning pregnancy, breastfeeding, using nicotine products, taking excluded antidepressants or antihypertensives, outside the specified age/BMI range, or unable to provide childhood weight documentation are unlikely to qualify or benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians tailor weight-loss approaches based on whether a person's obesity began in childhood or adulthood.
How similar studies have performed: Previous research has identified metabolic differences related to age of obesity onset, but combining tissue biopsies with a tailored weight-loss intervention to compare childhood- versus adult-onset obesity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Montreal, Quebec and 1 other locations
- Concordia University PERFORM Centre — Montreal, Quebec, Canada (Recruiting)
- Concordia University PERFORM Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Sylvia Santosa — Concordia University, Montreal
- Study coordinator: Sylvia Santosa, R.D, Ph.D
- Email: s.santosa@concordia.ca
- Phone: 514-848-2424
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.