AN OPEN-LABEL, ACUTE CLINICAL TRIAL TO ASSESS THE LEVEL OF KETONE PRODUCTION FOLLOWING CONSUMPTION OF AVELA™ (R)-1,3-BUTANEDIOL IN AN ADULT POPULATION
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels)
研究概览
简要总结
The purpose of the pilot clinical trial described herein is to determine the level of ketone production [measured as β hydroxybutyrate (BHB)] following consumption of (R)-1,3-butanediol in a beverage and to record gastrointestinal (GI) symptomology, as well as any effects on alertness/sleepiness.
详细描述
Primary:
To evaluate the level of production of BHB following the consumption of 3 servings of Avela™, with consumption of each serving separated by 30 minutes and each serving providing 11.5 g of (R)-1,3-butanediol [total intake of 34.5 g of (R)-1,3-butanediol].
BHB levels will be measured using capillary whole blood from the fingertips using at home Keto-Mojo monitoring system (β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood).
Measurement Range: 0.1 - 8.0 mmol/L Measurement time (min): 0, 30, 60, 90, 120, 180, 240, 300
Secondary:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females, 18 to 65 years of age
- •BMI 18 to <35.0 kg/m2, inclusive
- •Weight ≥ 110 lbs
- •Subject is judged to be in good health on the basis of medical history
- •Subject is willing to fast for 12 hours prior to study start
- •Subject is willing to avoid alcohol and intense physical activity the day prior to and on the day of testing
- •Subject is capable of giving informed consent and complying with all study procedures/requirements.
排除标准
- •Previous GI disorders (e.g., inflammatory bowel disease, irritable bowel syndrome, history of surgery for weight loss, or gastroparesis)
- •Gastroenteritis in the 2 weeks preceding the study
- •Weight <110 lbs
- •History of alcohol or drug abuse
- •Previous diagnosis of neurological disorders, depression, or mental illness with psychosis
- •Unexplained alarm features (i.e., unintentional weight loss >10% body weight in the last 3 months, fevers, or blood in stools)
- •Use of an antibiotic or any medication impacting gut transit during the 2 weeks before the study
- •Constipation or diarrhea (defined as, on average, less than 3 stools per week or more than 3 stools per day, respectively)
- •Allergy to tree nuts
- •Women who are pregnant or breastfeeding
- •Persons with medical conditions affecting the pancreas, liver, thyroid, or gall bladder.
结局指标
主要结局
To evaluate the level of production of BHB measure of blood ketones levels (i.e., blood BHB levels)
时间窗: 0, 30, 60, 90, 120, 180, 240, and 300 minutes
β-Ketone, as beta-hydroxybutyrate, in fingertip capillary whole blood, Measurement Range: 0.1 - 8.0 mmol/L
次要结局
- To assess GI symptomology(0, 30, 60, 90, 120, 180, 240, and 300 minutes)
- To assess Sleepiness/alertness(0, 30, 60, 90, 120, 180, 240, and 300 minutes)