Combined diet + cold exposure group for Weight Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Weight Loss+2 MoreCaloric Restriction - Behavioral
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Weight Loss
  • Cold Exposure
  • Compulsive Eating

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

9 Primary · 14 Secondary · Reporting Duration: 8 weeks

8 weeks
Change from baseline energy intake at 8 weeks
Change from baseline fasting fullness using Visual Analogue scales at 8 weeks
Change from baseline in Resting energy expenditure at 8 weeks
Change from baseline in fasting desire to eat using Visual Analogue scales at 8 weeks
Change from baseline in fasting hunger using Visual Analogue scales at 8 weeks
Change from baseline in fasting prospective food consumption using Visual Analogue scales at 8 weeks
Change from baseline in post-prandial desire to eat using Visual Analogue scales at 8 weeks
Change from baseline in post-prandial fullness using Visual Analogue scales at 8 weeks
Change from baseline in post-prandial hunger using Visual Analogue scales at 8 weeks
Change from baseline in post-prandial prospective food consumption using Visual Analogue scales at 8 weeks
Changes from baseline in body composition at 8 weeks
Changes from baseline in body weight at 8 weeks
Changes from baseline in olfaction using the 'Sniffin Sticks' tests at 8 weeks
Changes from baseline in post-prandial explicit liking using the LFPQ at 8 weeks
Changes from baseline in post-prandial explicit wanting using the LFPQ at 8 weeks
Changes from baseline in post-prandial implicit wanting using the LFPQ at 8 weeks
Changes from baseline in shivering response activity at 8 weeks
Changes from baseline in thermal comfort at 8 weeks
Changes from baseline in thermal sensation at 8 weeks
Changes from baseline in total GLP-1 (EZGLP1T-36K) at 8 weeks
Changes from baseline in total Ghrelin (EZGRT-89K) at 8 weeks
Changes from baseline in total Leptin (EZHL-80SK) at 8 weeks
Changes from baseline in total PYY (EZHPYYT66K) at 8 weeks

Trial Safety

Trial Design

3 Treatment Groups

Combined diet + cold exposure group
1 of 3
Only diet group
1 of 3
Only cold exposure group
1 of 3

Experimental Treatment

78 Total Participants · 3 Treatment Groups

Primary Treatment: Combined diet + cold exposure group · No Placebo Group · N/A

Combined diet + cold exposure group
Behavioral
Experimental Group · 1 Intervention: Caloric Restriction · Intervention Types: Behavioral
Only diet group
Behavioral
Experimental Group · 1 Intervention: Caloric Restriction · Intervention Types: Behavioral
Only cold exposure group
Other
Experimental Group · 1 Intervention: Cold intervention · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Caloric Restriction
2018
Completed Phase 3
~570

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks

Who is running the clinical trial?

University of OttawaLead Sponsor
177 Previous Clinical Trials
246,838 Total Patients Enrolled
4 Trials studying Weight Loss
572 Patients Enrolled for Weight Loss
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,233 Previous Clinical Trials
24,676,574 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

Eligibility Criteria

Age 18 - 55 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are weight-stable (±2 kg last 6 months).
You must be sedentary for at least 2 hours per week.

Who else is applying?

What state do they live in?
New Hampshire100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Ottawa100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%

How responsive is this trial?

Typically responds via
Email100.0%
Most responsive sites:
  1. University of Ottawa: < 48 hours
Average response time
  • < 2 Days