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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)
Must not have
Previous history of inflammatory disease
Untreated thyroid or pituitary disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests three weight loss methods: a diet plan, cold exposure, and a combination of both. It targets people who want to lose weight. The diet helps by reducing calorie intake, cold exposure helps by making the body burn more calories to stay warm, and combining both methods might be more effective.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had an inflammatory disease in the past.
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I have not received treatment for thyroid or pituitary disease.
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I have been diagnosed with a psychiatric condition like depression, anxiety, or an eating disorder.
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I have a history of stroke.
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I need insulin based on a glucose tolerance test.
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I have had cancer before.
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I have a history of blood circulation problems in my limbs.
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I am currently receiving treatment for asthma.
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I have a known kidney or liver condition.
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I take medication that could affect my heart or metabolism.
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I have gone through menopause.
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I had surgery that caused me to enter menopause.
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I have a history of heart disease.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
219 Previous Clinical Trials
269,549 Total Patients Enrolled
4 Trials studying Weight Loss
572 Patients Enrolled for Weight Loss
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,385 Previous Clinical Trials
26,515,857 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
~21 spots leftby Oct 2025
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