Effect of Acute Exercise on Food Intake and Energy Expenditure Following a Gastric Bypass (NCT04348617) | Clinical Trial Compass
UnknownNot Applicable
Effect of Acute Exercise on Food Intake and Energy Expenditure Following a Gastric Bypass
Canada30 participantsStarted 2021-05-15
Plain-language summary
This pilot study will use a crossover design to explore the effects of acute exercise following bariatric surgery on food intake, energy expenditure, appetite, food reward, appetite hormones, and inflammatory response. Participants will take part in a moderate-intensity exercise session and control condition of 50 minutes. The energy balance will be assessed for 3 days following the condition by giving the participants all the food they can consume for 3 days and having them wear an accelerometer.
The investigators hypothesize that post-gastric bypass participants with higher weight regain will have a higher compensation in response to exercise, thus an increase in food intake and/or a decrease in total energy expenditure after exercise compared to participants with less weight regain; also post-gastric bypass participants with a higher weight regain will have a lower inflammatory response to exercise compared to the group with less weight regain.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* declare to be an adult (≥ 18 years old)
* self-declared physically inactive (practicing less than 150 min/week of moderate to high intensity physical activity)
* received a gastric bypass Roux-en-Y more than 24 months ago at the Ottawa Hospital
* have regained weight ≤5%/year of total weight loss at nadir or ≥15%/year (n=15 regain)
Exclusion Criteria:
* be pregnant, breastfeeding or menopausal
* have depressive symptoms (score ≥16 at the Center Epidemiologic Depression-Scale)
* take medication that may influence appetite or weight loss
* declare they cannot walk for 50 minutes
* be classified as high risk according to the stratification model of the ACSM (people with heart disease, Peripheral vascular or cerebrovascular disease, chronic obstructive pulmonary disease, asthma, interstitial lung disease or cystic fibrosis, type 1 and 2 diabetes, thyroid disorders, kidney or liver disease) and not having medical authorization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of energy intake between rest and exercise conditions (kcal/d)
Timeframe: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
2
Change of total energy expenditure post-experimentation between rest and exercise conditions (kcal/d)
Timeframe: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2