Safety and Tolerability of Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Adverse Events- type
研究概览
简要总结
The purpose of the study is to determine if an oral ketone beverage is safe and well-tolerated during moderate intensity exercise in participants with long-chain fatty acid oxidation disorders and if it will raise blood ketones to levels similar to that reported among normal healthy subjects.
详细描述
Purpose: Subjects with long-chain fatty acid oxidation disorders (LC-FAOD) do not make ketones during fasting or with exercise. Ketones are an important alternative energy substrate during moderate exercise, sparing the oxidation of glucose and providing a source of ATP to the central nervous system and exercising muscle. Fatty acid oxidation in the liver is required to make ketones. Subjects with a LC-FAOD cannot generate ketones because of their block in fatty acid oxidation during exercise. Providing ketones in an oral ketone beverage may increase blood ketones with exercise to levels normally observed in humans.
Aim: To determine the safety and tolerability of an oral ketone beverage during moderate intensity exercise among subjects with a LC-FAOD compared to an isocaloric maltodextrin beverage, and to determine blood ketone concentrations.
Hypothesis
Oral consumption of a ketone beverage before moderate intensity exercise will be safe and well-tolerated, and will raise blood ketones among subjects with a LC-FAOD to concentrations similar to that reported in the literature among normal healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Sachets of the ketone or maltodextrin powder are coded and packaged identically. The bionutrition unit will prepare the beverage and maintain the randomization code and the code for the ketone and maltodextrin products.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of VLCAD, LCHAD/TFP or CPT2 deficiency
- •speak English
- •willing to complete 2 moderate intensity exercise treadmills
排除标准
- •subjects actively participating in another research study that prohibits their participation
- •pregnant females
- •subjects with diabetes or taking medications to treat diabetes
结局指标
主要结局
Adverse Events- type
时间窗: 2 hours after product intake
Description of Adverse events: categorical
Abdominal discomfort
时间窗: 2 hours after product intake
visual analogue scale (VAS) 0-10
Gastric reflux
时间窗: 2 hours after product intake
visual analogue scale (VAS) 0-10
Nausea
时间窗: 2 hours after product intake
visual analogue scale (VAS) 0-10
Adverse Events- incidence
时间窗: 2 hours after product intake
Number of Adverse events
Adverse Events- severity
时间窗: 2 hours after product intake
Severity of adverse event: grade 1-5
Decreased appetite
时间窗: 2 hours after product intake
visual analogue scale (VAS) 0-10
Adverse Events- causal relationship
时间窗: 2 hours after product intake
Yes/No related to product intake
Diarrhea
时间窗: 2 hours after product intake
visual analogue scale (VAS) 0-10
Headache
时间窗: 2 hours after product intake
visual analogue scale (VAS) 0-10
次要结局
- Blood Ketones(20 minutes after moderate intensity exercise)
- Blood Lactate(20 minutes after moderate intensity exercise)
- Respiratory Exchange Ratio(peak 40 minute exercise)
- Heart Rate(peak 40 minute exercise)
- Blood Glucose(20 minutes after moderate intensity exercise)
- Blood Creatine Kinase(20 minutes after moderate intensity exercise)
- Perceived exertion(peak 40 minute exercise)
- Blood Pressure(peak 40 minute exercise)
研究者
Melanie B Gillingham
Associate Professor
Oregon Health and Science University