Exogenous Ketones and Behavior (ExoKet)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Levels of ketones (ß-Hydroxybutyrate)
研究概览
简要总结
The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.
详细描述
This study investigates the effects of exogenous ketone ester on behavior, cognition, and metabolism over one week of consumption. Using a within-subjects, randomized, crossover design, participants will undergo two phases: one with the ketone ester supplement and one with a calorie- and taste-matched placebo. The study includes four lab visits: visits 1 and 3 mark the first day of each intervention, while visits 2 and 4 mark the last day. During each visit, participants will complete behavioral tasks, questionnaires, and blood tests. Additionally, participants will record their food intake via an app and collect stool samples throughout the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consent to participate
- •Fluent in German
- •Physically healthy. No regular medication
- •No drug use 1 week prior to the study
- •BMI 18-31 kg/m2
排除标准
- •Former or current illnesses of:
- •Brain or mind (including eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache; depression or anxiety disorder excluded)
- •Heart or blood circulation
- •Gastro-intestinal or endocrine disorders
- •Liver or kidney disorders
- •Electrolyte imbalance
- •Other serious past or present medical conditions (for example, metabolic syndrome, diabetes, cancer)
- •Pregnancy
- •Extreme athletes (>2h/day intense work-out; casual cycling or walking is ok)
- •Menopause (post menopause is ok)
- •Ketogenic diet, ketogenic supplement intake, intermittent fasting or calorie restricted diet during preceding 4 weeks of study participation
- •Fear of blood draw
结局指标
主要结局
Levels of ketones (ß-Hydroxybutyrate)
时间窗: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Glucose Values
时间窗: every 15 Minutes from visit 1 to visit 2 and again from visit 3 to visit 4
Continuous Glucose Monitoring through sensors applied to skin
Subjective anxiety levels
时间窗: on day 8 of each intervention arm (visit 2 and 4)
reported by participants on visual analog scale (1-7) during Virtual Reality. 1 being no anxiety to 7 being high anxiety
Competitive confidence in a competition task
时间窗: on day 8 of each intervention arm (visit 2 and 4)
based on a task paradigm by Goette et al., 2015
Blood Glucose
时间窗: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Risk propensity on a decision-making task
时间窗: on day 8 of each intervention arm (visit 2 and 4)
The choice (accept/reject) between a risk/gamble or safe option, based on a task paradigm by Liu et al. (2021)
Performance in Dual Task
时间窗: on day 1 of each intervention arm (visit 1 and 3)
based on a task paradigm by Szameitat et al., 2002
Electrocardiogram (heart rate)
时间窗: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrophysiological recording
Anxiety behavior in Virtual Reality
时间窗: on day 8 of each intervention arm (visit 2 and 4)
Using different scenes in Virtual Reality, parameters of motion behavior such as speed (measured in meters per second) and distance walked (measured in meters) will be assessed using motion tracking technology. These measurements will be combined to generate a composite score of anxiety-related motion behavior.
Delay Discounting behavior in a computerized task
时间窗: on day 1 of each intervention arm (visit 1 and 3)
based on a task paradigm by Eisenstein et al. 2015
Insulin
时间窗: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Ghrelin
时间窗: baseline and + 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Electrocardiogram (heart rate variability)
时间窗: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrophysiological recordings
Subjective stress levels
时间窗: on day 8 of each intervention arm (visit 2 and 4)
reported by participants on visual analog scale (1-7) during Virtual Reality. 1 being no stress to 7 being high stress
Levels of cortisol
时间窗: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Electrodermal Activity
时间窗: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrophysiological recordings
次要结局
- Stress Eating Questionnaire(baseline (visit 1))
- Trait Anxiety Questionnaire(baseline before visit 1)
- State Anxiety Questionnaire(on day 1 and 8 of each intervention arm (visit 1,2,3,4))
- Personality Questionnaire(baseline (visit 1))
- Gut microbiome(on day 8 of each intervention arm (visit 2 and 4))
- Depression Questionnaire(baseline, and on day 8 of each intervention arm (visit 1, 2, and 4))
- Social Anxiety Questionnaire(baseline, and on day 8 of each intervention arm (visit 1, 2, and 4))
- Flow Questionnaire(on day 1 of each intervention arm (visit 1 and 3))
- Dominance Questionnaire(baseline, and on day 8 of each intervention arm (visit 1, 2, and 4))
- Stress Questionnaire(baseline, and on day 8 of each intervention arm (visit 1, 2, and 4))
- Subjective anxiety levels(5 days of each intervention arm)
- Daily food intake(5 days of each intervention arm)
- Interoception Questionnaire(on day 8 of each intervention arm (visit 2 and 4))
- Mood Questionnaire(on day 1 and 8 of each intervention arm (visit 1,2,3,4))
- Impulsivity Questionnaire(baseline (visit 1))
- Emotional Eating Questionnaire(baseline (visit 1))
- Autonomy Questionnaire(on day 8 of each intervention arm (visit 2 and 4))
- Inhibition Questionnaire(baseline (visit 1))
- Subjective stress levels(5 days of each intervention arm)
- Chronotype Questionnaire(baseline (visit 1))
研究者
Prof. Dr. Soyoung Q Park
Prof. Dr.
German Institute of Human Nutrition