Effects of exogenous ketones on appetite in adults with obesity

The Effect of Exogenous Ketones on Appetite in Adults With or Without Obesity

This study is testing whether taking ketone supplements can help control appetite in adults with obesity compared to those without obesity.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 19 Years to 45 Years
• Sex: All
• Sponsor: University of British Columbia (other)
• Drugs / interventions: cart
• Locations: 1 site (Kelowna, British Columbia)
• Trial ID: NCT06327464 on ClinicalTrials.gov

What this trial studies

This study investigates how exogenous ketone supplements influence appetite and dietary intake in adults with obesity compared to those without obesity. Participants will undergo a randomized, single-blind, cross-over design, where they will experience two in-lab visits: one with the ketone supplement and one with a placebo. The study aims to assess changes in appetite hormones and energy expenditure following the ingestion of the supplement. Additionally, the research will consider the impact of menstrual cycle phases on the results for female participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19-45 with a BMI between 18.5 and 40.0 who are either sedentary or recreationally active.

Not a fit: Patients who are not within the specified age range or BMI, or who are pregnant or lactating, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new dietary strategies for managing appetite and obesity.

How similar studies have performed: Previous studies have shown promising effects of exogenous ketones on appetite in healthy adults, making this approach potentially beneficial but still somewhat novel in the context of obesity.

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

Where this trial is running

Kelowna, British Columbia

• University of British Columbia - Okanagan — Kelowna, British Columbia, Canada (RECRUITING)

Study contacts

• Study coordinator: Sarah Purcell, PhD

Conditions: Appetite, Obesity, Ketones, Appetitive Behavior, appetite, energy expenditure, exogenous ketones, dietary intake