Cold, Appetite and Weight Loss in Individuals With Obesity

NCT05076357 | Unknown

• 1 other identifier: H-09-19-4928
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Change from baseline energy intake at 8 weeks

  Energy intake will be measured both in the laboratory and in the free-living state for 3 days with a validated food menu (McNeil, 2012) and the Food Processor SQL from ESHA Research, Inc. Measures will be taken at baseline and after intervention.

  8 weeks

• Change from baseline in fasting hunger using Visual Analogue scales at 8 weeks

  Measures of fasting hunger using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention

  8 weeks

• Change from baseline in fasting desire to eat using Visual Analogue scales at 8 weeks

  Measures of fasting desire to eat using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention

  8 weeks

• Change from baseline fasting fullness using Visual Analogue scales at 8 weeks

  Measures of fasting fullness using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention

  8 weeks

• Change from baseline in fasting prospective food consumption using Visual Analogue scales at 8 weeks

  Measures of fasting prospective food consumption using Visual Analogue scales will be performed in fasting state (12h) at baseline and in the end of the weight loss intervention

  8 weeks

• Change from baseline in post-prandial hunger using Visual Analogue scales at 8 weeks

  Measures of post-prandial hunger using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention

  8 weeks

• Change from baseline in post-prandial desire to eat using Visual Analogue scales at 8 weeks

  Measures of post-prandial desire to eat using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention

  8 weeks

• Change from baseline in post-prandial fullness using Visual Analogue scales at 8 weeks

  Measures of post-prandial fullness using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention

  8 weeks

• Change from baseline in post-prandial prospective food consumption using Visual Analogue scales at 8 weeks

  Measures of post-prandial prospective food consumption using Visual Analogue scales will be taken at 30,60,90,120,150,180min after breakfast at baseline and in the end of the weight loss intervention

  8 weeks

Secondary Outcomes (14)

• Change from baseline in Resting energy expenditure at 8 weeks

  8 weeks

• Changes from baseline in post-prandial explicit liking using the LFPQ at 8 weeks

  8 weeks

• Changes from baseline in post-prandial explicit wanting using the LFPQ at 8 weeks

  8 weeks

• Changes from baseline in post-prandial implicit wanting using the LFPQ at 8 weeks

  8 weeks

• Changes from baseline in olfaction using the 'Sniffin Sticks' tests at 8 weeks

  8 weeks

Study Arms (3)

Only diet group

EXPERIMENTAL

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

Behavioral: Caloric Restriction

Only cold exposure group

EXPERIMENTAL

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.

Other: Cold intervention

Combined diet + cold exposure group

EXPERIMENTAL

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.

Behavioral: Caloric Restriction

Interventions

Caloric Restriction BEHAVIORAL

-30% of participants total energy requirements

Combined diet + cold exposure group; Only diet group

Cold intervention OTHER

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

Only cold exposure group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ottawa: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Ottawa

Ottawa, Ontario, K1N6N5, Canada

RECRUITING

MeSH Terms

Conditions

Weight Loss; Appetitive Behavior; Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Eric Doucet, PhD

  University of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luzia Jaeger-Hintze, PhD

CONTACT

613-562-5800; lhintze@uottawa.ca

Eric Doucet, Prof

CONTACT

613-562-5800; edoucet@uottawa.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This study is an 8 week weight loss intervention with 3 randomly assigned groups: DIET, cold exposure (CE), and DIET+CE. 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. 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.

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: October 13, 2021
• Study Start: February 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: October 31, 2024
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)