NCT05076357|Unknown
Cold, Appetite and Weight Loss in Individuals With Obesity
Cold Exposure, Appetite Control and Weight Loss in Individuals Living With Obesity
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Cold Exposure, Appetite Control and Weight Loss in Individuals Living With Obesity
Sponsor study identifier
interventional
78
1 country
1
Study Start
February 1, 2022
Actual (reported)Primary Completion
August 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 26, 2021
Actual (reported)October 13, 2021
Actual (reported)February 1, 2022
Actual (reported)August 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
Dietary energy prescription at -30% of Energy requirements (50% carbohydrate; 30% fat; 20% protein) during 8 weeks. Follow up with a registered dietitian.
No dietary intervention. Visit at laboratory every 2nd day during the 8-week intervention to undergo the cold exposure as follows: 2 weeks of exposure at 18 degrees, 2 weeks of exposure at 14 degrees and 4 weeks of 10 degrees of exposure during 90 min.
-30% of participants total energy requirements
Sessions of 90min each every 2nd day involving cold exposure
University of Ottawa
Ottawa, Ontario, K1N6N5, Canada
McInnis K, Larocque A, Beauregard N, Hintze LJ, Finlayson G, Haman F, Doucet E. Energy intake and energy expenditure are minimally impacted by acute cold exposure in individuals living with obesity. Int J Obes (Lond). 2025 Aug;49(8):1654-1661. doi: 10.1038/s41366-025-01809-2. Epub 2025 May 23.
Eric Doucet, PhD
University of Ottawa
First Submitted
April 26, 2021
First Posted
October 13, 2021
Study Start
February 1, 2022
Actual (reported)8 weeks
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
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
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
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
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
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
Change from baseline in Resting energy expenditure at 8 weeks
8 weeks
Changes from baseline in post-prandial explicit liking using the LFPQ at 8 weeks
8 weeks
Changes from baseline in post-prandial explicit wanting using the LFPQ 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
Dietary energy prescription at -30% of Energy requirements (50% carbohydrate; 30% fat; 20% protein). Follow up with a registered dietitian. Visit at laboratory every 2nd day during the 8-week intervention to undergo the cold exposure as follows: 2 weeks of exposure at 18 degrees, 2 weeks of exposure at 14 degrees and 4 weeks of 10 degrees of exposure during during 90 min.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 27, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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