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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

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

0 / 15Eligibility criteria met