The Effect of Exogenous Ketones on Appetite in Adults With or Without Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Acylated ghrelin area under the curve (AUC)
研究概览
简要总结
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.
详细描述
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 appetite visits: one with the exogenous ketone supplement and one without. After the baseline/screening visit, individuals will be randomized to either placebo/ketone or ketone/placebo study visit order in a 1:1 manner using online software (http://www.randomization.com). A washout period of at least 7 days will occur between study visits. For females, every attempt will be made to book these visits in the same menstrual cycle phase (according to self-reported menstrual cycle history) or estimated phase (for individuals not taking hormonal contraceptives or with a hormonal IUD).
Screening and baseline visit (~1 hour):
Individuals who consent to enroll in the study will be scheduled for a ~1 hour visit to confirm eligibility, measure body composition, and review study day procedures. Height and weight will be collected to confirm eligibility. Participants will also complete questionnaires to collect data on basic demographics and medical history, menstrual cycle history (for females), food preferences for the run-in and study day diets, screening for disordered eating (EATS-26) and alcohol or drug abuse (CAGE).
Data on participant's fat mass (FM), fat-free mass (FFM), body fat percent and bone mineral density will be collected using a full body dual X-ray absorptiometry (DEXA; Hologic Model A). Body composition variables will be expressed in absolute terms and controlling for height (e.g. FM index: FM [kg]/height [m2]); FFM will also be expressed in relation to FM (FM:FFM).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Current or previous major comorbidities, by self-report, including:
- •Cardiovascular diseases
- •Diabetes (type 1 or type 2)
- •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
研究组 & 干预措施
Ketone supplement condition first
干预措施: Exogenous ketones (Dietary Supplement)
Ketone supplement condition second
干预措施: Exogenous ketones (Dietary Supplement)
结局指标
主要结局
Acylated ghrelin area under the curve (AUC)
时间窗: 3 hours
Acylated ghrelin pre-breakfast and 60, 120, and 180 minutes after breakfast
次要结局
- Satiety rating from visual analog scale(3 hours)
- Dietary energy intake at a single meal(1 hour)
- Free-living dietary energy intake(1.5 days)
- Glucagon-like peptide 1 area under the curve (AUC)(3 hours)
- Insulin area under the curve (AUC)(3 hours)
- Hunger rating from visual analog scale(3 hours)
- Postprandial energy expenditure(3 hours)
- Peptide-YY(3-36) area under the curve (AUC)(3 hours)
- Glucose area under the curve (AUC)(3 hours)
- Leptin area under the curve (AUC)(3 hours)
- Prospective food consumption rating from visual analog scale(3 hours)
- Desire to eat rating from visual analog scale(3 hours)
研究者
Sarah Purcell
Assistant Professor
University of British Columbia