protocolSection identificationModule nctId: NCT06327464, orgStudyIdInfo id: 23-03228, briefTitle: Exogenous Ketones and Appetite, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2025-04-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-03-25, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of British Columbia, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Appetite, conditions: Obesity, conditions: Ketones, conditions: Appetitive Behavior, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 22, type: ESTIMATED, armsInterventionsModule interventions name: Exogenous ketones, outcomesModule primaryOutcomes measure: Acylated ghrelin area under the curve (AUC), secondaryOutcomes measure: Peptide-YY(3-36) area under the curve (AUC), secondaryOutcomes measure: Glucagon-like peptide 1 area under the curve (AUC), secondaryOutcomes measure: Insulin area under the curve (AUC), secondaryOutcomes measure: Glucose area under the curve (AUC), secondaryOutcomes measure: Leptin area under the curve (AUC), secondaryOutcomes measure: Hunger rating from visual analog scale, secondaryOutcomes measure: Satiety rating from visual analog scale, secondaryOutcomes measure: Prospective food consumption rating from visual analog scale, secondaryOutcomes measure: Desire to eat rating from visual analog scale, secondaryOutcomes measure: Dietary energy intake at a single meal, secondaryOutcomes measure: Free-living dietary energy intake, secondaryOutcomes measure: Postprandial energy expenditure, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of British Columbia - Okanagan, city: Kelowna, state: British Columbia, zip: V1V1V7, country: Canada, contacts name: Sarah Purcell, PhD, role: CONTACT, phone: 2508079827, email: sarah.purcell@ubc.ca, geoPoint lat: 49.88307, lon: -119.48568, hasResults: False