Recruiting

Observational Study

Sponsor:

University of Ottawa

Code:

NCT05076357

Conditions

Weight Loss

Cold Exposure

Appetitive Behavior

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Caloric Restriction

Cold intervention

Study Details

Brief summary:

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.

Conditions

Weight Loss

Cold Exposure

Appetitive Behavior

Study ID

NCT05076357

Start date

Feb 1, 2022

Status verified date

Apr, 2022

Completion date

Oct 31, 2024

Anticipated

Primary completion date

Aug 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Present a 27≥BMI,
  • Present a waist circumference >88 cm
  • Must be weight-stable (±2 kg last 6 months)
  • Must be sedentary (<2 times/week of 30 min of continuous exercise)
  • Must be able to read in English
  • Must to present no history of alcohol or drugs abuse

In addition, Women will be included if:

• Must be pre-menopausal with a regular menstrual cycle

Exclusion Criteria:

  • present any history or evidence of cardiovascular disease
  • present any history or evidence of peripheral vascular disease
  • present any history or evidence of stroke
  • present a current diagnosis of an axis 1 psychiatric disorder (i.e. mood, anxiety and eating disorders);
  • be insulin dependent (75g oral glucose tolerance test)
  • present a known renal and/or liver disease
  • asthma requiring therapy
  • plasma cholesterol > 8 mmol/L
  • systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg
  • present previous history of inflammation disease
  • present previous history of cancer
  • present untreated thyroid or pituitary disease
  • present a regular consumption of medications that could affect cardiovascular function and/or metabolism (i.e. MAO inhibitors, pressor agents, warfarin, anticonvulsants, phenylbutazone, or tricyclic antidepressants)
  • present food allergies
  • be smoker
  • present alcohol intake that exceeds recommendations or alcoholism
  • present current addictions to opiates, cocaine or stimulants
  • be pregnant or planning to become pregnant over the course of the study
  • be peri- or post-menopausal
  • have had surgically induced menopause

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Only diet group

Dietary energy prescription at -30% of Energy requirements (50% carbohydrate; 30% fat; 20% protein) during 8 weeks. Follow up with a registered dietitian.

experimental: Only cold exposure group

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.

experimental: Combined diet + cold exposure group

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.

Interventions

Caloric Restriction

-30% of participants total energy requirements

Cold intervention

Sessions of 90min each every 2nd day involving cold exposure

Primary outcome measure

  • Change from baseline energy intake at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline in fasting hunger using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline in fasting desire to eat using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline fasting fullness using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline in fasting prospective food consumption using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline in post-prandial hunger using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline in post-prandial desire to eat using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline in post-prandial fullness using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]
  • Change from baseline in post-prandial prospective food consumption using Visual Analogue scales at 8 weeks [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Luzia Jaeger-Hintze, PhD

613-562-5800lhintze@uottawa.ca

Eric Doucet, Prof

613-562-5800edoucet@uottawa.ca

Locations

University of Ottawa

Recruiting

Ottawa, Ontario, Canada, K1N6N5

Contacts

Luzia Jaeger Hintze, PhD

lhintz@uottawa.ca

More Information

Sponsor

University of Ottawa

Last update posted

Apr 27, 2022

Last verified

Apr, 2022

Keywords

  • weight loss
  • appetite
  • cold exposure
  • obesity
  • nutritional intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Ottawa on 2022-04-27.