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Cold Exposure + Diet for Weight Loss

N/A
Recruiting
Led By Eric Doucet, PhD
Research Sponsored by University of Ottawa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women must be pre-menopausal with a regular menstrual cycle
Must be sedentary (exercise less than 2 times a week for 30 minutes continuously)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial is an 8-week weight loss intervention with 3 randomly assigned groups: DIET, cold exposure (CE), and DIET+CE. The study will last a total of 13 weeks. All participants will have a screening session, two experimental sessions at baseline, and two experimental sessions after the intervention.

Who is the study for?
This trial is for English-reading, sedentary adults with obesity (BMI of 27 or greater and waist circumference >88 cm), who have been weight-stable in the last 6 months. Participants should be pre-menopausal women with regular menstrual cycles and no history of alcohol or drug abuse. Those with certain medical conditions, high blood pressure, cholesterol levels, or on specific medications are excluded.Check my eligibility
What is being tested?
The study tests an 8-week weight loss intervention comparing three groups: diet only (DIET), cold exposure only (CE), and a combination of both (DIET+CE). Each group will undergo lab sessions before and after the intervention to measure effects. The DIET groups receive weekly nutritional consultations; CE groups attend bi-daily cold exposure sessions.See study design
What are the potential side effects?
Potential side effects are not explicitly listed in the provided information but may include discomfort from cold exposure such as chills or shivering, hunger from caloric restriction, possible changes in mood or energy levels due to dieting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a pre-menopausal woman with regular periods.
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I exercise less than 2 times a week for 30 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline energy intake at 8 weeks
Change from baseline fasting fullness using Visual Analogue scales at 8 weeks
Change from baseline in fasting desire to eat using Visual Analogue scales at 8 weeks
+6 more
Secondary outcome measures
Change from baseline in Resting energy expenditure at 8 weeks
Changes from baseline in body composition at 8 weeks
Changes from baseline in body weight at 8 weeks
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Only diet groupExperimental Treatment1 Intervention
Dietary energy prescription at -30% of Energy requirements (50% carbohydrate; 30% fat; 20% protein) during 8 weeks. Follow up with a registered dietitian.
Group II: Only cold exposure groupExperimental Treatment1 Intervention
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.
Group III: Combined diet + cold exposure groupExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caloric Restriction
2018
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

University of OttawaLead Sponsor
206 Previous Clinical Trials
266,063 Total Patients Enrolled
4 Trials studying Weight Loss
572 Patients Enrolled for Weight Loss
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,339 Total Patients Enrolled
1 Trials studying Weight Loss
Eric Doucet, PhDPrincipal InvestigatorUniversity of Ottawa
4 Previous Clinical Trials
170 Total Patients Enrolled
1 Trials studying Weight Loss
30 Patients Enrolled for Weight Loss

Media Library

Caloric Restriction Clinical Trial Eligibility Overview. Trial Name: NCT05076357 — N/A
Weight Loss Research Study Groups: Combined diet + cold exposure group, Only diet group, Only cold exposure group
Weight Loss Clinical Trial 2023: Caloric Restriction Highlights & Side Effects. Trial Name: NCT05076357 — N/A
Caloric Restriction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05076357 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary aims of this medical research?

"This clinical trial will assess its primary outcome over an 8 week period, which is the variation of post-prandial desire to eat as indicated through a Visual Analogue Scale. Secondary objectives are tracking resting energy expenditure and explicit wanting using the Leeds Preference Food Questionnaire (LFPQ), in addition to olfaction measured with Sniffin Sticks tests at 90 minutes after breakfast both before and after intervention."

Answered by AI

Is recruitment for this research endeavor still open?

"This clinical trial is actively accepting participants, having been first posted on February 1st 2022 and most recently updated on April 19th. Clinicaltrials.gov reports provide further details."

Answered by AI

Is the age range of this research study restricted to those over 45 years old?

"The requirements to be accepted into this study stipulate participants must fall between 18 and 55 years of age. There are 236 trials that accommodate minors while 718 clinical studies accept seniors as volunteers."

Answered by AI

How many participants are being welcomed into this research project?

"Affirmative. The clinical trial appears to be actively recruiting according to the data found on clinicialtrials.gov, where it was first posted on February 1st 2022 and last updated April 19th 2022. 78 patients are needed at one medical facility in order for this study to reach its goals."

Answered by AI

Is it possible to participate in this experiment?

"This scientific experiment seeks 78 volunteers aged 18-55 that possess a BMI of 27 or greater, waist circumference exceeding 88 cm, pre-menopausal with consistent menstrual cycles, and no history of substance abuse. Additionally, applicants must be literate in English and present evidence of weight stability over the past 6 months as well as exhibiting sedentary behaviour (<2x/week)."

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
How old are they?
18 - 65
What site did they apply to?
University of Ottawa
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Ottawa: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Cold, Appetite and Weight Loss in Individuals With Obesity
Eric Doucet 2022. "Cold, Appetite and Weight Loss in Individuals With Obesity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05076357.
All > Weight Loss
~25 spots leftby Apr 2025
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