Exogenous Ketones and Appetite

NCT06327464 | Completed

• 1 other identifier: 23-03228
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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, lower glucagon-like peptide 1 (GLP-1) and peptide-YY (PYY; associated with satiety) compared to people without obesity. Given the favorable effects of exogenous ketones on appetite previously observed in healthy adults of normal body weight, it is possible that these supplements can alter appetite hormones in a manner that may closer match that observed in people without obesity. To explore this research question, investigators will conduct a randomized single-blind cross over study to characterize appetite and dietary intake after ingestion of an exogenous ketone supplement within adults with obesity (compared a control condition without exogenous ketones) and compared to adults without obesity. The research team will also explore differences in postprandial energy expenditure and fuel utilization. Twenty-two healthy young- and middle-aged adults will be included (up to n=26 enrolled). In addition to a baseline visit to measure body composition, participants will undergo two 4.5-hour study visits, one of which will include a ketone diol supplement and one will have a placebo. Participants will be given a 1-day run-in diet prior to each study day to support energy balance. On each study day visit, participants will undergo a resting metabolic rate test (indirect calorimetry) followed by a fasting appetite rating and blood sample collection. Participants will then be provided with a standard breakfast meal (one with the ketone supplement and one with placebo). Appetite ratings and blood sample collection will be repeated 60, 120, and 180 minutes after the meal. Indirect calorimetry will be completed after the 30, 90, and 150 minute assessments. After the 180-minute timepoint, participants will be provided with a buffet-like lunch meal with instructions to eat as much or as little as they would like to determine ad libitum dietary intake at a single meal. To assess free-living ad libitum dietary intake, participants will receive 1.5 days of food boxes tailored to their preferences, with uneaten food returned at the end of the 1.5-day period. This study will be the first to assess the impact of exogenous ketones on appetite in obesity and would help inform future weight loss intervention trials.

Conditions

Appetite; Obesity; Ketones; Appetitive Behavior

Keywords

appetite; energy expenditure; exogenous ketones; dietary intake

Outcome Measures

Primary Outcomes (1)

• Acylated ghrelin area under the curve (AUC)

  Acylated ghrelin pre-breakfast and 60, 120, and 180 minutes after breakfast

  3 hours

Secondary Outcomes (12)

• Peptide-YY(3-36) area under the curve (AUC)

  3 hours

• Glucagon-like peptide 1 area under the curve (AUC)

  3 hours

• Insulin area under the curve (AUC)

  3 hours

• Glucose area under the curve (AUC)

  3 hours

• Leptin area under the curve (AUC)

  3 hours

Study Arms (2)

Ketone supplement condition first

OTHER

Dietary Supplement: Exogenous ketones

Ketone supplement condition second

OTHER

Dietary Supplement: Exogenous ketones

Interventions

Exogenous ketones DIETARY_SUPPLEMENT

Consumption of a single exogenous ketone supplement with breakfast

Ketone supplement condition first; Ketone supplement condition second

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia - Okanagan

Kelowna, British Columbia, V1V1V7, Canada

Location

MeSH Terms

Conditions

Obesity; Ketosis; Appetitive Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Behavior, Animal; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 25, 2024
• Study Start: April 17, 2024
• Primary Completion: July 26, 2025
• Study Completion: July 26, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)