Metabolic Effects of Medium-Chain Fatty Acids in Patients With Medium-Chain Acyl-CoA Dehydrogenase Deficiency and Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ketone Bodies
研究概览
简要总结
The aim of this project is to investigate the physiological effects of intake of long-chain fatty acids (LCFA) and medium-chain fatty acids (MCFA) in patients with Medium-Chain Acyl-CoA Dehydrogenase Deficiency (MCADD) and healthy individuals
详细描述
Male and female MCADD patients and healthy individuals will be included in this study which is a randomized intervention study in a cross over design consisting of two separate test days.
The study involves two test days of four hours each, during which the participants ingests either medium-chain fatty acids (MCFA) or long-chain fatty acids (LCFA) in the form of triacylglycerol oils. The order of fatty acid oils ingested is determined by randomization.
Furthermore, a 3rd test day will be performed to evaluate ectopic fat deposition in the liver and the heart by using MRI scans, with no prior intake of MCFA or LCFA.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •MCADD patients:
- •Male or female
- •Age between 18-80 years old
- •Diagnosed Medium-chain acyl-CoA dehydrogenase deficiency (MCADD
- •Inclusion Criteria Healthy Participants:
- •Male or female
- •Age between 18-80 years old
排除标准
- •both MCADD patients and healthy participants:
- •Kidney- or liver disease
- •Use of beta blockers or diuretics
- •Pregnant, lactating or planning to become pregnant within the study period
- •Regular intake of substantial amounts of coconut oil, palm kernel oil or any other source abundant in MCFA
- •Ongoing cancer treatment
- •Metabolic or absorptive disorders, gastric bypass operation, or use of medication affecting metabolism or food absorption
- •Inability, physically or mentally, to comply with the procedure required by the study protocol as evaluated by the primary investigator, study manager or clinical responsible
研究组 & 干预措施
MCADD Patients
干预措施: Long-Chain Fatty Acid (LCFA) (Other)
Healthy Participants
干预措施: Medium-Chain Fatty Acid (MCFA) (Other)
Healthy Participants
干预措施: Long-Chain Fatty Acid (LCFA) (Other)
MCADD Patients
干预措施: Medium-Chain Fatty Acid (MCFA) (Other)
结局指标
主要结局
Ketone Bodies
时间窗: During both individual test days
To measure the effect of Medium-Chain Fatty Acid (MCFA) and Long-Chain Fatty Acid (LCFA) on circulating ketone body concentrations.
次要结局
- Resting metabolic rate(During both individual test days)
- Vasodilator Function(During both individual test days)
- Fatty Acid Composition(During both individual test days)
- Metabolites(During both individual test days)
- Respiratory exchange ratio(During both individual test days)
- Hepatokines(During both individual test days)
- Beta cell function(During both individual test days)
- Ectopic Fat Deposition(On a separate 3rd test day)
研究者
Andreas Mæchel Fritzen
Associate Professor
University of Copenhagen