Exogenous Ketones and Appetite

Launched by UNIVERSITY OF BRITISH COLUMBIA · Mar 21, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating how exogenous ketones, which are supplements that can help increase ketone levels in the body, might affect appetite in adults with obesity. The researchers want to understand if these supplements can change appetite hormones in a way that makes them more similar to those in people without obesity. The study will include healthy adults aged 19 to 45 years who have a body mass index (BMI) between 18.5 and 40.0. Participants should be either sedentary or moderately active, and women must be premenopausal or using birth control.

Participants in the trial can expect to take part in two study visits, where they will consume either the ketone supplement or a placebo (a non-active substance). Each visit will last about 4.5 hours and will include tests to measure their metabolism, appetite, and food intake after a standard breakfast. They will also receive tailored food boxes to assess their eating habits over a day and a half. This study is important because it is the first to look at how exogenous ketones might help manage appetite in people with obesity, which could lead to new strategies for weight loss.

Gender

ALL

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