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"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change of energy intake between rest and exercise conditions (kcal/d)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Change of energy intake between rest and exercise conditions (kcal/d)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- Change of blood ghrelin concentration during experimentation and between conditions (pg/ml)(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)(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)(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(Baseline)
- Baseline Eating behavior score; The Three Factor Eating Questionnaire(Baseline)
- Presence of binge eating behaviors; Eating Disorder Examination Questionnaire and Binge Eating Scale(Baseline)
- Baseline Kg of fat mass(Baseline)
- Baseline total energy expenditure(Baseline)
- Change of blood IL-10 concentration during experimentation and between conditions (pg/ml)(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)(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)(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)(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)(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)(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)(At least one week after baseline evaluation (visit 2) and 15 days to a maximum of 2 months after visit 2)
研究者
Aurelie Baillot
Professor
Universite du Quebec en Outaouais