ObesityExoABariNCT04348617
Effect of Acute Exercise on Food Intake and Energy Expenditure Following a Gastric Bypass
A study testing Moderate exercise and Rest in people with Obesity, run by Universite du Quebec en Outaouais at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Moderate exercise and Rest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Aurelie Baillot
Gatineau, Quebec, j9a2y7
aurelie baillot, 8195953900 ext. 1995, aurelie.baillot@uqo.ca
About this study
Official title: A Pilot Study " Effect of Acute Exercise on Food Intake and Energy Expenditure Following a Gastric Bypass: A Better Understanding of Weight Maintenance for Better Intervention"
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.
Read the detailed description
Objectives.
- Explore the feasibility of a multicenter study in post-GB patients;
- Explore the effects of acute exercise on food intake and energy expenditure post-GB;
- Explore the effects of acute exercise on the hormonal and inflammatory response post-exercise.
This pilot study will employ crossover design. The Behavioural and Metabolic Research Unit (BMRU) at the School of Human Kinetics of the University of Ottawa will coordinate and standardize the project between the sites. The participants will need to go 5 times to one of the 3 evaluation sites (University of Ottawa: BMRU, Montreal: University of Montreal, School of kinesiology and physical activity or University of Sherbrooke: Research Aging Center of CIUSSS - CHUS).
Considering this is a pilot project, no sample size calculations were conducted. Based on existing studies, 30 participants should be sufficient to achieve the preliminary objectives of this study.
The participants will be asked to present themselves at the evaluation centre on 5 occasions (1 preliminary, 2 experimental, 2 to return leftovers and accelerometers).
During the visits 1, 2 and 4 (1 preliminary and 2 experimental (exercise and control)), the participants will arrive at 7:00 a.m. at the laboratory after 12 hours nocturnal fast. At 9:00 a.m., they will consume a standardized personalized breakfast. Participants will choose themselves the breakfast they want from a validated menu. They will be informed that they can consume the desired quantity of each product; the quantities will be measured to assure the breakfast for the other visits is identical.
During the 1st session, depressive symptoms, the body composition (DEXA), resting metabolic rate and anthropometrics (weight, height, waist circumference) will be measured before breakfast. Afterwards, their socio-demographic information, motivation to eat and binge eating behaviors will be assessed. At 10:30 a.m., participants will perform submaximal exercise for 30 minutes to familiarize themselves with the treadmill, determine the speed and incline of the treadmill to achieve 55% estimated HRR and obtain an estimation of EE during the experimental condition. Subsequently to the first visit, the participants will wear an accelerometer for 7 days and bring it back for the 2nd visit. The day before the 2nd visit, the participants will fill out a food intake journal of the last 24 hours in order to consume the exact same foods (items, quantities and timeframe) the day before the 3rd session.
At least one week after the 1st session, participants will present themselves to the evaluation site for the 2nd session to take part in one of the 2 experimental conditions (control and exercise), which will be randomly assigned and spaced a minimum of 15 days and a maximum of 2 months, yet to be performed the same day of the week. Women will only be tested between day 1 and 8 of their follicular phase. During the experimental conditions, participants will perform exercise on a treadmill (50 minutes at 55% of estimated HRR) (exercise condition) or the controlled condition (inactive period of calm and stress-free reading) at 10:30 a.m. Sixty minutes following exercise or the inactive period, an ad libitum buffet will be served to assess caloric and macro-nutritional intake. Appetite sensations will be assessed in the morning during fasting, before/after exercise, before/after ad libitum buffet as well as 1 and 2 hours after eating. Food rewards will be measured before and 1 hour after the meal. Blood samples will be collected 5 times by a nurse after a catheter has been installed, representing a total of 108 ml of blood collected (morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before the buffet) to analyze appetite-related hormones (ghrelin, peptide YY (PYY) and glucagon-like peptide-1 (GLP-1)) and inflammatory parameters (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1). Finally, participants will wear an accelerometer (Actigraph® GT3X+) for 3 days following the sessions to determine their total EE outside of the laboratory. They will also leave with 3 days' worth of meals of their choice and will need to bring back any leftovers in order to calculate their caloric intake.
In the exercise condition, a 50-minute effort at 55% of the estimated HRR will be performed on the treadmill following a 3-minute warm-up at 2.5 km/h and will be followed by a 2-minute active recovery period at 2.5 km/h then sitting for 3 minutes. The estimated maximum heart rate will be calculated from the most accurate prediction equation for a population with obesity: 208 - 0.7 × age. The heart rate will be monitored with a heart rate monitor throughout the exercise and recovery to ensure that the intensity of the exercise is maintained.
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/student 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 (34). 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 in their original containers. The selected and prepared foods will be weighted to the nearest gram using an electronic food scale before being consumed or placed in coolers. The macronutrient composition of foods and beverages consumed will be determined and analyzed in Ottawa using Food Processor SQL software (version 9.6.2; ESHA Research).
Appetite and satiety will be measured using a computer-based visual analogue scale (VAS) (0-100mm). The desire to eat, hunger, satiety and potential food consumption will be assessed. The level of satiety will be evaluated using the "satiety quotient" method adapted from Green et al, which quantify variations in subjective appetite measurements (mm) for each 100kcal of food consumed. The Leeds Food Preference Questionnaire (LFPQ) will be used to assess food reward, i.e. explicit food pleasure and implicit and explicit food motivation.
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The blood plasma samples collected for hormone analysis (ghrelin, PYY, GLP-1) will be collected in EDTA tubes. Immediately after blood sampling, a precise protocol will be used for each targeted hormone to preserve their integrity.
- Conditions
- Obesity
- Being tested
- Moderate exercise, Rest
- Keywords
- Bariatric Surgery, Appetite, Food intake, Energy expenditure, Food reward, Appetite hormones, Inflammatory response, acute exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate exerciseOther
Also called Walking
50 minutes of moderate exercise on treadmill
RestOther
50 minutes of rest or sedentary activity
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Moderate exercise; Other: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Appetite and satiety will be measured using a computer-based visual analogue scale (VAS) (0-100mm) in the morning during fasting, before/after exercise, before/after ad libitum buffet as well as 1 and 2 hours after eating. The desire to eat, hunger, satiety and potential food consumption will be assessed using the following questions: 1) "How intense is your desire to eat?" (Very weak - very strong); 2) "How hungry are you?" Not at all hungry - as hungry as ever); 3) "How full are you feeling?" (Not at all - Completely), and 4) "How much food do you think you can eat?" (Nothing at all - A large quantity). Higher scores mean higher desire to eat, appettite, and a lower satiety.
Measured: 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
The Leeds Food Preference Questionnaire (LFPQ) will be used before and 1 hour after the meal during the experimental conditions to assess food reward, i.e. explicit food pleasure and implicit and explicit food motivation. This questionnaire is a validated computerized procedure, during which 16 personalized different food images will be presented to participants for approximately 10 minutes. Food images were previously classified according to fat content (rich vs. low) and/or taste (salty vs. sweet) to form four categories: high fat and salt, low fat and salt, high fat and sugar, and low fat and sugar.
Measured: 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
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: 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)
Resting energy expenditure will be evaluated by indirect calorimetry with continuous evaluation of O2 and CO2 sampled with a transparent hood, after calibration of the gas analyzers.
Measured: Baseline
Exercise energy expenditure (kcal/d)
Exercise energy expenditure will be evaluated by indirect calorimetry with continuous evaluation of O2 and CO2 sampled with a mouthpiece, after calibration of the gas analyzers.
Measured: 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
Change of blood ghrelin concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The blood plasma samples collected for ghrelin analysis will be collected in EDTA tubes. Immediately after blood sampling, a precise protocol will be used to preserve their integrity. The analysis of ghrelin will be carried out with ELISA kits specific to ghrelin: Millipore, Etobicoke, ON, Canada. Blood samples will be collected 5 times during the experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood Glucagon-like peptide-1 (GLP-1) concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The blood plasma samples collected for GLP-1 analysis will be collected in EDTA tubes. Immediately after blood sampling, a precise protocol will be used to preserve their integrity. The analysis of GLP-1 will be carried out with ELISA kits specific to ghrelin: Linco Research, St Louis, MO, USA. Blood samples will be collected 5 times during the experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood peptide YY (PYY) concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The blood plasma samples collected for PYY analysis will be collected in EDTA tubes. Immediately after blood sampling, a precise protocol will be used to preserve their integrity. The analysis of PYY will be carried out with ELISA kits specific to PYY: Linco Research, St Louis, MO, USA. Blood samples will be collected 5 times during the experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Baseline Kg of fat free mass; Dual Energy X-ray Absorptiometry
It will be evaluated by Dual Energy X-ray Absorptiometry.
Measured: Baseline
Baseline Eating behavior score; The Three Factor Eating Questionnaire
The Three Factor Eating Questionnaire, also called Eating Inventory, developed by Stunkard et Messick will be used to identify different eating behaviours or motivations to eat. This 51-question, self-administered questionnaire identifies three "factors": cognitive restraint (21 questions) which measures dietary self-regulation; disinhibition (16 questions) which assesses loss of control over eating and susceptibility to hunger (14 questions), which describes subjective feelings of hunger and cravings.All TFEQ items are coded with either 0 or 1 point leading to maximum sum scores of 21 points for the domain of 'cognitive restraint', 16 points for 'disinhibition' and 14 points for 'hunger'. Higher scores indicate stronger characteristic values in the domains.
Measured: Baseline
Presence of binge eating behaviors; Eating Disorder Examination Questionnaire and Binge Eating Scale
The first section of the Eating Disorder Examination Questionnaire consists of 22 items that allow participants to record the frequency and intensity with which they adopted inappropriate attitudes and behaviours over the past four weeks. A score greater than or equal to 4 is considered clinically significant and suggests a diagnosis of an eating disorder.
The Binge Eating Scale is a validated 16-item self-administered questionnaire. For each item, the participant must choose from several sentences the wording that best corresponds to their current situation. The score can vary between 0 and 3 or between 0 and 2 for each item. A total score (obtained from the sum of the scores of each of the 16 items) greater than or equal to 18 indicates significant binge eating behaviors.
Measured: Baseline
Baseline Kg of fat mass
It will be evaluated by Dual Energy X-ray Absorptiometry.
Measured: Baseline
Baseline total energy expenditure
Using an accelerometer (Actigraph® GT3X+) worn on the right side at the waist for 7 days after the preliminary visit (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 7 days of wearing the accelerometer.
Measured: Baseline
Change of blood IL-10 concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: 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-1ra concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: 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-8 concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood TNF-α concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood sTNFR concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood MIP-1β concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood MCP-1 concentration during experimentation and between conditions (pg/ml)
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The inflammatory profile (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1) will be evaluated with X-Map technology using Luminex 200 (EMD Millipore, Burlington, MA, USA). Blood samples will be collected 5 times during each experimental visits: morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before lunch.
Measured: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 May 2021
- Primary completion31 Mar 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will take part in a randomized exercise and control (rest) condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universite du Quebec en Outaouais
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa, Université de Sherbrooke, Université de Montréal
- Responsible party
- Principal investigator, Aurelie Baillot, Universite du Quebec en Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348617
- Sponsor's protocol ID
- MP-31-2020-323
- Acronym
- ExoABari
- Status last verified
- Oct 2022
- First submitted
- 26 Mar 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study " Effect of Acute Exercise on Food Intake and Energy Expenditure Following a Gastric Bypass: A Better Understanding of Weight Maintenance for Better Intervention"
- ClinicalTrials.gov ID
- NCT04348617
- Acronym / sponsor ID
- ExoABari / MP-31-2020-323
- Conditions
- Obesity
- Keywords
- Bariatric Surgery, Appetite, Food intake, Energy expenditure, Food reward, Appetite hormones, Inflammatory response, acute exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universite du Quebec en OutaouaisUniversity, hospital or other
- Collaborators
- University of Ottawa, Université de Sherbrooke, Université de Montréal
- Study start
- 15 May 2021 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 16 Apr 2020 (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.
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.
Detailed description
Objectives.
- Explore the feasibility of a multicenter study in post-GB patients;
- Explore the effects of acute exercise on food intake and energy expenditure post-GB;
- Explore the effects of acute exercise on the hormonal and inflammatory response post-exercise.
This pilot study will employ crossover design. The Behavioural and Metabolic Research Unit (BMRU) at the School of Human Kinetics of the University of Ottawa will coordinate and standardize the project between the sites. The participants will need to go 5 times to one of the 3 evaluation sites (University of Ottawa: BMRU, Montreal: University of Montreal, School of kinesiology and physical activity or University of Sherbrooke: Research Aging Center of CIUSSS - CHUS).
Considering this is a pilot project, no sample size calculations were conducted. Based on existing studies, 30 participants should be sufficient to achieve the preliminary objectives of this study.
The participants will be asked to present themselves at the evaluation centre on 5 occasions (1 preliminary, 2 experimental, 2 to return leftovers and accelerometers).
During the visits 1, 2 and 4 (1 preliminary and 2 experimental (exercise and control)), the participants will arrive at 7:00 a.m. at the laboratory after 12 hours nocturnal fast. At 9:00 a.m., they will consume a standardized personalized breakfast. Participants will choose themselves the breakfast they want from a validated menu. They will be informed that they can consume the desired quantity of each product; the quantities will be measured to assure the breakfast for the other visits is identical.
During the 1st session, depressive symptoms, the body composition (DEXA), resting metabolic rate and anthropometrics (weight, height, waist circumference) will be measured before breakfast. Afterwards, their socio-demographic information, motivation to eat and binge eating behaviors will be assessed. At 10:30 a.m., participants will perform submaximal exercise for 30 minutes to familiarize themselves with the treadmill, determine the speed and incline of the treadmill to achieve 55% estimated HRR and obtain an estimation of EE during the experimental condition. Subsequently to the first visit, the participants will wear an accelerometer for 7 days and bring it back for the 2nd visit. The day before the 2nd visit, the participants will fill out a food intake journal of the last 24 hours in order to consume the exact same foods (items, quantities and timeframe) the day before the 3rd session.
At least one week after the 1st session, participants will present themselves to the evaluation site for the 2nd session to take part in one of the 2 experimental conditions (control and exercise), which will be randomly assigned and spaced a minimum of 15 days and a maximum of 2 months, yet to be performed the same day of the week. Women will only be tested between day 1 and 8 of their follicular phase. During the experimental conditions, participants will perform exercise on a treadmill (50 minutes at 55% of estimated HRR) (exercise condition) or the controlled condition (inactive period of calm and stress-free reading) at 10:30 a.m. Sixty minutes following exercise or the inactive period, an ad libitum buffet will be served to assess caloric and macro-nutritional intake. Appetite sensations will be assessed in the morning during fasting, before/after exercise, before/after ad libitum buffet as well as 1 and 2 hours after eating. Food rewards will be measured before and 1 hour after the meal. Blood samples will be collected 5 times by a nurse after a catheter has been installed, representing a total of 108 ml of blood collected (morning during fasting, before/after exercise or control condition, 30 minutes after exercise or control condition and before the buffet) to analyze appetite-related hormones (ghrelin, peptide YY (PYY) and glucagon-like peptide-1 (GLP-1)) and inflammatory parameters (IL-6, IL-10, IL-1ra, IL-8, TNF-α, sTNFR, MIP-1β, MCP-1). Finally, participants will wear an accelerometer (Actigraph® GT3X+) for 3 days following the sessions to determine their total EE outside of the laboratory. They will also leave with 3 days' worth of meals of their choice and will need to bring back any leftovers in order to calculate their caloric intake.
In the exercise condition, a 50-minute effort at 55% of the estimated HRR will be performed on the treadmill following a 3-minute warm-up at 2.5 km/h and will be followed by a 2-minute active recovery period at 2.5 km/h then sitting for 3 minutes. The estimated maximum heart rate will be calculated from the most accurate prediction equation for a population with obesity: 208 - 0.7 × age. The heart rate will be monitored with a heart rate monitor throughout the exercise and recovery to ensure that the intensity of the exercise is maintained.
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/student 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 (34). 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 in their original containers. The selected and prepared foods will be weighted to the nearest gram using an electronic food scale before being consumed or placed in coolers. The macronutrient composition of foods and beverages consumed will be determined and analyzed in Ottawa using Food Processor SQL software (version 9.6.2; ESHA Research).
Appetite and satiety will be measured using a computer-based visual analogue scale (VAS) (0-100mm). The desire to eat, hunger, satiety and potential food consumption will be assessed. The level of satiety will be evaluated using the "satiety quotient" method adapted from Green et al, which quantify variations in subjective appetite measurements (mm) for each 100kcal of food consumed. The Leeds Food Preference Questionnaire (LFPQ) will be used to assess food reward, i.e. explicit food pleasure and implicit and explicit food motivation.
Blood samples taken with a catheter placed in the anterior ulnar vein of the dominant arm will be collected by a qualified nurse. The blood plasma samples collected for hormone analysis (ghrelin, PYY, GLP-1) will be collected in EDTA tubes. Immediately after blood sampling, a precise protocol will be used for each targeted hormone to preserve their integrity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will take part in a randomized exercise and control (rest) condition.
| Arm | Type | Receives |
|---|---|---|
| Exercise-Rest | Experimental | Other: Moderate exercise, Other: RestThis 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. |
| Rest-Exercise | Experimental | Other: Moderate exercise, Other: RestThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Moderate exerciseAlso: Walking50 minutes of moderate exercise on treadmill | Other | Exercise-Rest, Rest-Exercise |
| Rest50 minutes of rest or sedentary activity | Other | Exercise-Rest, Rest-Exercise |
Primary outcome
Change of energy intake between rest and exercise conditions (kcal/d)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
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.
Change of total energy expenditure post-experimentation between rest and exercise conditions (kcal/d)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
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.
20 secondary outcomes
Change of appetite sensation score during experimentation and between conditions; visual analog scale (0-100mm)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline
Exercise energy expenditure (kcal/d)
Time frame: 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
Change of blood ghrelin concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood Glucagon-like peptide-1 (GLP-1) concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood peptide YY (PYY) concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Baseline Kg of fat free mass; Dual Energy X-ray Absorptiometry
Time frame: Baseline
Baseline Eating behavior score; The Three Factor Eating Questionnaire
Time frame: Baseline
Presence of binge eating behaviors; Eating Disorder Examination Questionnaire and Binge Eating Scale
Time frame: Baseline
Baseline Kg of fat mass
Time frame: Baseline
Baseline total energy expenditure
Time frame: Baseline
Change of blood IL-10 concentration during experimentation and between conditions (pg/ml)
Time frame: 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-1ra concentration during experimentation and between conditions (pg/ml)
Time frame: 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-8 concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood TNF-α concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood sTNFR concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood MIP-1β concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Change of blood MCP-1 concentration during experimentation and between conditions (pg/ml)
Time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate exercise and Rest in people with Obesity, run by Universite du Quebec en Outaouais at 1 site 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aurelie Baillot (8199437561, aurelie.baillot@uqo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of energy intake between rest and exercise conditions (kcal/d) (time frame: At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2). The study lists 2 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 2 Nov 2022.