Cold Exposure, Appetite Control and Weight Loss in Individuals Living With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change from baseline in post-prandial desire to eat using Visual Analogue scales at 8 weeks
研究概览
简要总结
This study is an 8 week weight loss intervention with 3 randomly assigned groups: DIET, cold exposure (CE), and DIET+CE. The study will be a total of 13 weeks. All participants will undergo a screening session, two experimental sessions at baseline and two experimental sessions after the intervention.
There will be a control (ambient) experimental session and a cold exposure experimental session These will be done in a randomized order both before and after the intervention. Therefore, a total of 5 lab visits will be required for all participants regardless of group outside of their assigned group intervention. Participants in the CE and DIET+CE groups will report to the laboratory every 2nd day for the 8 week intervention to undergo cold exposure as outlined below. The DIET and DIET+CE groups will have a weekly nutritional consultation at the lab as well as a weekly check-in with the nutritionist via text, phone, or email. Participants will be randomly assigned a group after completing the screening session and prior to the experimental session.
详细描述
This study is an 8 week weight loss intervention with 3 randomly assigned groups: DIET, cold exposure (CE), and DIET+CE. The study will be a total of 13 weeks. All participants will undergo a screening session outlined below. There will be 4 experimental sessions, 2 before and 2 after the intervention. There will be one week between each session. The timeline will be:
- Screening
- Experimental session 1
- Experimental session 2
- Intervention
- Experimental session 3
- Experimental session 4. There will be a control (ambient) experimental session and a cold exposure experimental session (outlined below). These will be done in a randomized order both before and after the intervention. Therefore, a total of 5 lab visits will be required for all participants regardless of group outside of their assigned group intervention. Participants in the CE and DIET+CE groups will report to the laboratory every 2nd day for the 8 week intervention to undergo cold exposure as outlined below. The DIET and DIET+CE groups will have a weekly nutritional consultation at the lab as well as a weekly check-in with the nutritionist via text, phone, or email. Participants will be randomly assigned a group after completing the screening session and prior to the experimental session. Participants cannot be assigned prior to consenting, as this will bias the randomization process and make it irrelevant. They will have all 3 groups explained to them prior to consenting but will not be assigned until after screening.
SCREENING Informed consent will be collected and verification of inclusion criteria. Participants will be invited to rate the food items the most consume from different categories: high fat sweet, low fat sweet, high fat savory, low fat savory. The results will be used for the Leeds Food preference Questionnaire (LFPQ) that will be applied in the experimental sessions. Measures of height and weight will be collected. Afterwards, participants will be given an accelerometer (Actical-Mini Mitter Co. Inc.) to measure their activity levels for 1 week.
EXPERIMENTAL SESSIONS 7h15 - Anthropometrics and DEXA. Participants will be asked to arrive after a 12h overnight fast and having refrained from vigorous activities for 48h. Body weight and height (HR-100 Height Rod and BWB-800AS Digital Scale, Tanita Corporation of America, Inc. Arlington Heights, Illinois, USA) will be measured. A Dual Energy X-Ray Absorptiometry (DEXA) (Lunar Prodigy, GE Medical Systems).scan will be used to measure bone density, fat mass and lean body mass. Participants will have to lie on an examination table, fully clothed, while a low intensity x-ray will scan the entire body. The measurements take 15 minutes.
7h30 - Insertion of catheter. A qualified nurse will place an intravenous catheter into the ante-cubital vein distal to the elbow to take blood draws at various points outlined below. A total of X collections will be done, with each collections being 10 mL for a total of 80 mL. The first will be taken immediately after insertion. This will be followed by a short rest period. Blood samples will be kept for 10 years after publication, and then will be destroyed through the university biohazard waste disposal process. Blood draws will occur at the following additional time points: 9h, 9h40, 10h20, 11h, 11h40, 12h20, 1h..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Present a 27≥BMI,
- •Present a waist circumference >88 cm
- •Must be weight-stable (±2 kg last 6 months)
- •Must be sedentary (<2 times/week of 30 min of continuous exercise)
- •Must be able to read in English
- •Must to present no history of alcohol or drugs abuse
- •In addition, Women will be included if:
- •Must be pre-menopausal with a regular menstrual cycle
排除标准
- •present any history or evidence of cardiovascular disease
- •present any history or evidence of peripheral vascular disease
- •present any history or evidence of stroke
- •present a current diagnosis of an axis 1 psychiatric disorder (i.e. mood, anxiety and eating disorders);
- •be insulin dependent (75g oral glucose tolerance test)
- •present a known renal and/or liver disease
- •asthma requiring therapy
- •plasma cholesterol > 8 mmol/L
- •systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
- •present previous history of inflammation disease
- •present previous history of cancer
- •present untreated thyroid or pituitary disease
- •present a regular consumption of medications that could affect cardiovascular function and/or metabolism (i.e. MAO inhibitors, pressor agents, warfarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants)
- •present food allergies
- •be smoker
- •present alcohol intake that exceeds recommendations or alcoholism
- •present current addictions to opiates, cocaine or stimulants
- •be pregnant or planning to become pregnant over the course of the study
- •be peri- or post-menopausal
- •have had surgically induced menopause
结局指标
主要结局
Change from baseline in post-prandial desire to eat using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of post-prandial desire to eat using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention
Change from baseline fasting fullness using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of fasting fullness using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention
Change from baseline in post-prandial prospective food consumption using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of post-prandial prospective food consumption using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention
Change from baseline energy intake at 8 weeks
时间窗: 8 weeks
Energy intake will be measured both in the laboratory and in the free-living state for 3 days with a validated food menu (McNeil, 2012) and the Food Processor SQL from ESHA Research, Inc. Measures will be taken at baseline and after intervention.
Change from baseline in fasting hunger using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of fasting hunger using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention
Change from baseline in fasting desire to eat using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of fasting desire to eat using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention
Change from baseline in post-prandial fullness using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of post-prandial fullness using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention
Change from baseline in fasting prospective food consumption using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of fasting prospective food consumption using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention
Change from baseline in post-prandial hunger using Visual Analogue scales at 8 weeks
时间窗: 8 weeks
Measures of post-prandial hunger using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention
次要结局
- Changes from baseline in post-prandial explicit wanting using the LFPQ at 8 weeks(8 weeks)
- Changes from baseline in thermal sensation at 8 weeks(8 weeks)
- Change from baseline in Resting energy expenditure at 8 weeks(8 weeks)
- Changes from baseline in total Ghrelin (EZGRT-89K) at 8 weeks(8 weeks)
- Changes from baseline in total GLP-1 (EZGLP1T-36K) at 8 weeks(8 weeks)
- Changes from baseline in body weight at 8 weeks(8 weeks)
- Changes from baseline in shivering response activity at 8 weeks(8 weeks)
- Changes from baseline in thermal comfort at 8 weeks(8 weeks)
- Changes from baseline in total PYY (EZHPYYT66K) at 8 weeks(8 weeks)
- Changes from baseline in body composition at 8 weeks(8 weeks)
- Changes from baseline in post-prandial implicit wanting using the LFPQ at 8 weeks(8 weeks)
- Changes from baseline in olfaction using the 'Sniffin Sticks' tests at 8 weeks(8 weeks)
- Changes from baseline in total Leptin (EZHL-80SK) at 8 weeks(8 weeks)
- Changes from baseline in post-prandial explicit liking using the LFPQ at 8 weeks(8 weeks)
研究者
Eric Doucet
Full Professor
University of Ottawa