Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects
- Conditions
- Hypertriglyceridemia
- Interventions
- Other: DHA-NATOther: Placebo
- Registration Number
- NCT05953064
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 20
- Male
- Healthy
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description DHA-NAT DHA-NAT Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. Placebo Placebo Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.
- Primary Outcome Measures
Name Time Method Plasma triglyceride 0-240 minutes Change in incremental area-under-curve plasma triglyceride
- Secondary Outcome Measures
Name Time Method Gall bladder emptying: Cholecystokinin 0-240 minutes Cholecystokinin profile
Gastric emptying: Paracetamol 0-240 minutes Plasma acetaminphen profile
Stool quality Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours. Self-assessment of stool quality by the Bristol Stool Scale (1-7, where 1 = most solid and 7 = least solid)
Plasma GLP-1 0-240 minutes Plasma GLP-1 profile
Plasma N-acyl taurine species 0-240 minutes Profile of plasma n-acyl taurine species
Food intake (kcal) t=240 minutes kcal consumed of a standard ad libitum meal
Plasma triglyceride (TG) distribution 0-240 minutes total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG
Plasma ApoB48 0-240 minutes Plasma ApoB48 profile
Satiety, hunger and appetite 0-240 minutes Development during study day recorded by visual analogue scale (VAS), 0-10 cm where 0 = not in agreement with statement and 10 = in agreement with statement.
Plasma cholesterol 0-240 minutes Total cholesterol, HDL, LDL, VLDL, remnant cholesterol
Plasma level of glucose regulating hormones 0-240 minutes Insulin, glucagon and gastric inhibitory polypeptide
Plasma amino acids 0-240 minutes Total amino acids profile
Plasma bile acid species 0-240 minutes Plasma bile acid profile
Food intake (g) t=240 minutes Grams consumed of a standard ad libitum meal
Plasma free fatty acid species 0-240 minutes Total fatty acids profile
Plasma glucose 0-240 minutes Plasma glucose profile
Gall bladder emptying: Ultrasonography 0-240 minutes Difference in volume from most to least full
Trial Locations
- Locations (1)
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
🇩🇰Hellerup, Denmark