Weight Loss Clinical Trial
Official title:
Cold Exposure, Appetite Control and Weight Loss in Individuals Living With Obesity
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.
Status | Recruiting |
Enrollment | 78 |
Est. completion date | October 31, 2024 |
Est. primary completion date | August 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University of Ottawa | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Ottawa | Canadian Institutes of Health Research (CIHR) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline energy intake at 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. | 8 weeks | |
Primary | Change from baseline in fasting hunger using Visual Analogue scales at 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 | 8 weeks | |
Primary | Change from baseline in fasting desire to eat using Visual Analogue scales at 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 | 8 weeks | |
Primary | Change from baseline fasting fullness using Visual Analogue scales at 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 | 8 weeks | |
Primary | Change from baseline in fasting prospective food consumption using Visual Analogue scales at 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 | 8 weeks | |
Primary | Change from baseline in post-prandial hunger using Visual Analogue scales at 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 | 8 weeks | |
Primary | Change from baseline in post-prandial desire to eat using Visual Analogue scales at 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 | 8 weeks | |
Primary | Change from baseline in post-prandial fullness using Visual Analogue scales at 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 | 8 weeks | |
Primary | Change from baseline in post-prandial prospective food consumption using Visual Analogue scales at 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 | 8 weeks | |
Secondary | Change from baseline in Resting energy expenditure at 8 weeks | Resting energy expenditure will be measured at baseline and in the end the intervention | 8 weeks | |
Secondary | Changes from baseline in post-prandial explicit liking using the LFPQ at 8 weeks | explicit liking will be measured using a tool called Leeds Preference Food Questionnaire. Measures will be taken at baseline and at the end of the intervention | 8 weeks | |
Secondary | Changes from baseline in post-prandial explicit wanting using the LFPQ at 8 weeks | explicit wanting will be measured using a tool called Leeds Preference Food Questionnaire. Measures will be taken at baseline and at the end of the intervention | 8 weeks | |
Secondary | Changes from baseline in post-prandial implicit wanting using the LFPQ at 8 weeks | implicit wanting will be measured using a tool called Leeds Preference Food Questionnaire. Measures will be taken at baseline and at the end of the intervention | 8 weeks | |
Secondary | Changes from baseline in olfaction using the 'Sniffin Sticks' tests at 8 weeks | Olfaction will be measured using the Sniffin' Sticks (Burghart Instruments, Wedel, Germany), a 3-test battery of odorized markers that measure odor detection threshold, odor discrimination, and odor identification at 90 min after breakfast at baseline and after intervention | 8 weeks | |
Secondary | Changes from baseline in shivering response activity at 8 weeks | Changes in shivering response will be measured by surface electromyography (Delsys, Boston, MA, 02215, USA) from 7 muscles on the right side of the body:
trapezius, latissimus dorsi, pectoralis major, vastus lateralis, rectus femoris, vastus medialis, and biceps femoris. EMG will be collected at 1000Hz and analyzed using a custom-designed MATLAB algorithms (Mathworks, Natick, MA) at baseline and after intervention. |
8 weeks | |
Secondary | Changes from baseline in thermal comfort at 8 weeks | Changes in thermal comfort will be measured using a LIKERT scale type (-5 to +5) at baseline and after the intervention | 8 weeks | |
Secondary | Changes from baseline in thermal sensation at 8 weeks | Changes in thermal sensation will be measured using a LIKERT scale type (-5 to +5) at baseline and after the intervention | 8 weeks | |
Secondary | Changes from baseline in total Ghrelin (EZGRT-89K) at 8 weeks | Blood samples will be collected fasting and at 30-min interval for 3 h in tubes containing EDTA and Aprotinin (anti-protease). Changes in total Ghrelin will be assayed with commercially available ELISA (Millipore, Billerica, MA 01821 USA) at baseline and after the intervention. | 8 weeks | |
Secondary | Changes from baseline in total Leptin (EZHL-80SK) at 8 weeks | Blood samples will be collected fasting and at 30-min interval for 3 h in tubes containing EDTA and Aprotinin (anti-protease). Changes in total Leptin will be assayed with commercially available ELISA (Millipore, Billerica, MA 01821 USA) at baseline and after the intervention. | 8 weeks | |
Secondary | Changes from baseline in total GLP-1 (EZGLP1T-36K) at 8 weeks | Blood samples will be collected fasting and at 30-min interval for 3 h in tubes containing EDTA and Aprotinin (anti-protease). Changes in total GLP-1 will be assayed with commercially available ELISA (Millipore, Billerica, MA 01821 USA) at baseline and after the intervention. | 8 weeks | |
Secondary | Changes from baseline in total PYY (EZHPYYT66K) at 8 weeks | Blood samples will be collected fasting and at 30-min interval for 3 h in tubes containing EDTA and Aprotinin (anti-protease). Changes in total PYY will be assayed with commercially available ELISA (Millipore, Billerica, MA 01821 USA) at baseline and after the intervention. | 8 weeks | |
Secondary | Changes from baseline in body composition at 8 weeks | Changes in body composition will be measured using a DXA (Lunar Prodigy, GE Medical Systems) at baseline and after intervention. | 8 weeks | |
Secondary | Changes from baseline in body weight at 8 weeks | Baseline and post intervention changes of body weight will be measured using a BWB-800AS Digital Scale from Tanita Corporation of America, Inc. Arlington Heights, Illinois, USA). | 8 weeks |
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