Obesity & OverweightACEONCT07515547
Acute and Chronic Effects of Obesity
An observational study of Obesity & Overweight and Metabolism Changes, run by Concordia University, Montreal at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Obesity & Overweight, Metabolism Changes, Lipid Metabolism
- What is being tested?
- Weight loss
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Apr 2025to Aug 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Sedentary or untrained individuals with body mass index between 30.0-39.9kg/m^2 (see conditions above).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Concordia University PERFORM Centre
Montreal, Quebec, H4B 1R6
Sylvia Santosa, +1 (514) 702-8898, s.santosa@concordia.ca
- Recruiting
Concordia University PERFORM Centre
Montreal, Quebec
Sylvia Santosa, +1 (514) 702-8898, s.santosa@concordia.ca
About this study
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
- Being tested
- Weight loss
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
A conventional weight loss program will be implemented for participants to lose approximately 10% of their starting body weight
| Study group | Role | What they receive |
|---|---|---|
| Childhood-onset obesity | Individuals who developed severe overweight or obesity during childhood (before puberty) Receives: Behavioral: Weight loss | |
| Adult-onset obesity | Individuals who developed obesity as adults Receives: Behavioral: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune cell quantification
Flow cytometry will be used to quantify immune cell levels in adipose tissue
Measured: 4 years
Pre-adipocyte and adipocyte characteristics
Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.
Measured: 5 years
Muscle and adipose tissue interaction
Cell culture interactions between myocytes and adipocytes will be evaluated to understand their interactions
Measured: 5 years
Blood inflammatory markers
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start30 Apr 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Concordia University, Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Montreal Children's Hospital of the MUHC
- Responsible party
- Sponsor
- Investigators
- Sylvia Santosa, Principal investigator, Concordia University, Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515547
- Sponsor's protocol ID
- 10000619
- Other IDs
- RGPIN-2020-06809
- Acronym
- ACEO
- Status last verified
- Apr 2025
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute and Chronic Effects of Obesity
- ClinicalTrials.gov ID
- NCT07515547
- Acronym / sponsor ID
- ACEO / 10000619
- Conditions
- Obesity & Overweight, Metabolism Changes, Lipid Metabolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Concordia University, MontrealUniversity, hospital or other
- Collaborators
- Montreal Children's Hospital of the MUHC
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Childhood-onset obesity | – | Behavioral: Weight lossIndividuals who developed severe overweight or obesity during childhood (before puberty) |
| Adult-onset obesity | – | Behavioral: Weight lossIndividuals who developed obesity as adults |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sedentary or untrained individuals with body mass index between 30.0-39.9kg/m^2 (see conditions above).
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight lossA conventional weight loss program will be implemented for participants to lose approximately 10% of their starting body weight | Behavioural | Adult-onset obesity, Childhood-onset obesity |
Primary outcome
Immune cell quantification
Time frame: 4 years
Flow cytometry will be used to quantify immune cell levels in adipose tissue
Pre-adipocyte and adipocyte characteristics
Time frame: 5 years
Cellular characteristics such as proliferation, differentiation and cellular senescence will measured.
Muscle and adipose tissue interaction
Time frame: 5 years
Cell culture interactions between myocytes and adipocytes will be evaluated to understand their interactions
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvia Santosa principal investigator
Concordia University, Montreal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Metabolism Changes, run by Concordia University, Montreal at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sylvia Santosa, R.D, Ph.D (514-848-2424 ext. 5841, s.santosa@concordia.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune cell quantification (time frame: 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.