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NCT Number: NCT07515547

Acute and Chronic Effects of Obesity

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.

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Key information

Conditions

Obesity & Overweight Body Weight Lipid Metabolism Metabolism Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Concordia University PERFORM Centre, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight Loss

Behavioral

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

Primary outcomes

  1. Immune cell quantification

    Time frame: 4 years

    Flow cytometry will be used to quantify immune cell levels in adipose tissue

  2. Pre-adipocyte and adipocyte characteristics

    Time frame: 5 years

    Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.

  3. Muscle and adipose tissue interaction

    Time frame: 5 years

    Cell culture interactions between myocytes and adipocytes will be evaluated to understand their interactions

  4. Blood inflammatory markers

    Time frame: 5 years

    The inflammatory cytokines (e.g. IL6, TNFα), chemokines (e.g. monocyte chemoattractant protein-1), genomics, and adipokines (e.g. leptin, adiponectin) in blood and adipose tissue via PCR, luminex or ELISA will be measured

Study contacts

Contact information is provided by the study sponsor or research team.

Kayla Toledano, Ph.D Student

CONTACT

[email protected]

5145884865

Sylvia Santosa, R.D, Ph.D

CONTACT

[email protected]

514-848-2424 ext. 5841

Sponsors and collaborators

Lead sponsor

Concordia University, Montreal

Other

Collaborators

  • Montreal Children's Hospital of the MUHC

Registry information

Acronym: ACEO

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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