Effect of Acute Exercise on Food Intake and Energy Expenditure Following a Gastric Bypass

NCT04348617 | Unknown

• 1 other identifier: MP-31-2020-323
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Bariatric Surgery; Appetite; Food intake; Energy expenditure; Food reward; Appetite hormones; Inflammatory response; acute exercise

Outcome Measures

Primary Outcomes (2)

• Change of energy intake between rest and exercise conditions (kcal/d)

  The energy intake and macronutrients from the ad libitum will be measured with the validated technique of the food menu. A total of 62 items will be on the menu to ensure that sufficient hot meals, snacks, fruits, vegetables and beverages are available to the participants. Briefly, participants will be invited to choose from this validated menu, their breakfast, the meals they would like to have for lunch and after lunch the meals they would like to eat for the next 3 days (from midnight to midnight). The research assistant will instruct them to consume as much of these products as they want. All selected foods will be prepared and measured according to the guidelines described above. The food and beverages selected for the 3 days will be packed in plastic containers or bottles, which will be placed in a portable cooler for the participants to take with them. They must return all leftovers, packaging and peels in their original containers.

  At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2

• Change of total energy expenditure post-experimentation between rest and exercise conditions (kcal/d)

  Total energy expenditure: Using an accelerometer (Actigraph® GT3X+) worn on the right side at the waist for 3 days following the experimental conditions (except during showering and aquatic physical activities), total EE will be estimate (ActiLife® Software). In parallel, the participant will have to complete a physical activity logbook during the 3 days of wearing the accelerometer.

  At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2

Secondary Outcomes (20)

• Change of appetite sensation score during experimentation and between conditions; visual analog scale (0-100mm)

  At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2

• Change of food rewards score during experimentation and between conditions, The Leeds Food Preference Questionnaire

  At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2

• Change of blood IL-6 concentration during experimentation and between conditions

  At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2

• Baseline resting energy expenditure (kcal/d)

  Baseline

• Exercise energy expenditure (kcal/d)

  Baseline and during the exercise condition = at least one week after baseline evaluation (visit 2) OR 15 days to a maximum of 2 months after visit 2

Study Arms (2)

Exercise-Rest

EXPERIMENTAL

This group will perform the exercise condition at least 1 week after the preliminary visit and will perform the resting condition a minimum of 15 days and a maximum of 2 months after the exercise condition.

Other: Moderate exercise; Other: Rest

Rest-Exercise

EXPERIMENTAL

This group will perform the resting condition at least 1 week after the preliminary visit and will perform the exercise condition a minimum of 15 days and a maximum of 2 months after the resting condition.

Other: Moderate exercise; Other: Rest

Interventions

Moderate exercise OTHER

50 minutes of moderate exercise on treadmill

Also known as: Walking

Exercise-Rest; Rest-Exercise

Rest OTHER

50 minutes of rest or sedentary activity

Exercise-Rest; Rest-Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universite du Quebec en Outaouais: lead
• University of Ottawa: collaborator
• Université de Sherbrooke: collaborator
• Université de Montréal: collaborator

Study Sites (1)

Aurelie Baillot

Gatineau, Quebec, j9a2y7, Canada

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Walking; RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

aurelie Baillot

CONTACT

8199437561; aurelie.baillot@uqo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will take part in a randomized exercise and control (rest) condition.

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: April 16, 2020
• Study Start: May 15, 2021
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

CA (1)