NCT05953064已完成不适用
Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (FEAST): a Randomised, Double-blind, Placebocontrolled, Crossover Study
University Hospital, Gentofte, Copenhagen1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma triglyceride
研究概览
简要总结
This study is an investigator-initiated, randomised, double-blind, placebo-controlled, cross-over human trial investigating the effect of DHA-NAT (C22:6 N-acyl taurine, an endogenous metabolite derived from the omega-3 fatty acid, docosahexaenoic acid) on postprandial plasma triglyceride levels following a high-fat meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 30 years
- •Body mass index between 18.5-25 kg/m2
- •Informed consent
- •Moderate level of physical activity assessed with IPAQ (short version)
排除标准
- •Use of fish-oil/omega-3 FA supplements within the last 3 months
- •Regular tobacco smoking or use of other nicotine-containing products
- •Allergy or intolerance to ingredients included in the standardised meals
- •Weekly intake of fish >350 g (23)
- •First-degree relatives with diabetes and/or glycated haemoglobin (HbA1c) >48 mmol/mol, familial hypercholesterolemia/hyperlipidemia
- •Anaemia (haemoglobin below 8.3 mmol/L)
- •Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times upper normal values (Normal values: ALAT < 70 U/L, ASAT <45 U/L)
- •Nephropathy (serum creatinine >105 μmol/L) and/or albuminuria (>30 mg/g albumin in urine))
- •History of hepatobiliary or gastrointestinal disorder(s)
- •Any physical or psychological condition, or ongoing medication, that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
研究组 & 干预措施
DHA-NAT
Experimental
Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.
干预措施: DHA-NAT (Other)
Placebo
Placebo Comparator
Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.
干预措施: Placebo (Other)
结局指标
主要结局
Plasma triglyceride
时间窗: 0-240 minutes
Change in incremental area-under-curve plasma triglyceride
次要结局
- Plasma free fatty acid species(0-240 minutes)
- Plasma GLP-1(0-240 minutes)
- Plasma N-acyl taurine species(0-240 minutes)
- Food intake (kcal)(t=240 minutes)
- Plasma triglyceride (TG) distribution(0-240 minutes)
- Plasma ApoB48(0-240 minutes)
- Satiety, hunger and appetite(0-240 minutes)
- Plasma cholesterol(0-240 minutes)
- Plasma level of glucose regulating hormones(0-240 minutes)
- Plasma amino acids(0-240 minutes)
- Plasma bile acid species(0-240 minutes)
- Gall bladder emptying: Cholecystokinin(0-240 minutes)
- Gastric emptying: Paracetamol(0-240 minutes)
- Stool quality(Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours.)
- Food intake (g)(t=240 minutes)
- Plasma glucose(0-240 minutes)
- Gall bladder emptying: Ultrasonography(0-240 minutes)
研究者
Filip Krag Knop
Principal Investigator, Clinical Professor
University Hospital, Gentofte, Copenhagen
研究点 (1)
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