Status:
RECRUITING
Exogenous Ketones and Appetite
Lead Sponsor:
University of British Columbia
Conditions:
Appetite
Obesity
Eligibility:
All Genders
19-45 years
Phase:
NA
Brief Summary
People with obesity have different appetitive responses to stimuli compared to people without obesity. For example, people with obesity have a blunted postprandial ghrelin ('hunger' hormone) response,...
Detailed Description
Overview: Investigators will conduct a randomized, single-blind cross-over study in adults with and without obesity. The study consists of one screening/baseline visit, plus two 4.5-hour in-lab appet...
Eligibility Criteria
Inclusion Criteria:
-
Age 19-45 years
-
Body mass index (BMI): 18.5 - 40.0 kg/m2
-
For females: Premenopausal, with regular menstrual cycle (every 21-38 days, by self-report) OR lack of regular menstrual cycles due to oral contraceptive or intrauterine device (IUD) use
-
Sedentary or recreationally active, defined as: <300 minutes per week of voluntary exercise at moderate intensity or greater over the past 12 weeks
-
Not currently pregnant or lactating, not planning to become pregnant in the next 12 weeks
-
Ability and willingness to fast for 12 hours before each study day visit
-
If applicable:
- For people who occasionally (i.e., <1x/day) use cannabis (including cannabidiol-based products): ability and willingness to abstain from cannabis for two days prior to each study day visit, the day of each study visit, and during each ad libitum diet phase.
- For people who use cannabis daily: ability and willingness to continue to use the exact same amount of cannabis as they normally use for two days prior to each study day visit, the day of each study visit, and during each ad libitum diet phase.
Exclusion Criteria:
-
Current or previous major comorbidities, by self-report, including:
- Cardiovascular diseases
- Diabetes (type 1 or type 2)
- Cancer
- Thyroid diseases
- Human immunodeficiency virus or hepatitis B or C
- Renal diseases
- Hepatic diseases
- Polycystic ovary syndrome
-
Uncontrolled/untreated (self-report):
- Hypertension
- Dyslipidemia
- Uncontrolled Ssleep disorders (e.g., insomnia)
- Any other condition that may affect appetite and energy balance
-
Currently or in the past six months:
- Use of regular medication or supplement that may affect appetite, energy balance, or sleep
- Regular use of tobacco or nicotine products
-
Starting any new prescription medication within two weeks of the first study day visit or during the study
-
Working night shifts or traveling across more than 2 time zones within two weeks of and throughout the study
-
Food intolerances or allergies that cannot be accommodated
-
History of surgical procedure for weight loss at any time (e.g., gastroplasty, gastric bypass, gastrectomy or partial gastrectomy, adjustable banding, gastric sleeve); history of extensive bowel resection for other reasons
-
Current alcohol or substance abuse (score >2 on the cut down-annoyed-guilty-eye opener [CAGE] questionnaire16)
-
Current or past history of eating disorders including anorexia nervosa, bulimia, binge eating disorder (self-report or score >20 on the Eating Attitudes Test - 26 [EATS-26] questionnaire17)
-
Weight loss >5% in past 12 weeks for any reason
Key Trial Info
Start Date :
April 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06327464
Start Date
April 17 2024
End Date
April 1 2025
Last Update
May 8 2024
Active Locations (1)
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1
University of British Columbia - Okanagan
Kelowna, British Columbia, Canada, V1V1V7