Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (FEAST): a Randomised, Double-blind, Placebocontrolled, Crossover Study

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Other: DHA-NAT
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DHA-NAT<br>Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. | Other: DHA-NAT<br>* Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid<br>* Other names: C22:6 N-acyl taurine;|
| Placebo Comparator: Placebo<br>Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. | Other: Placebo<br>* Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma triglyceride | Change in incremental area-under-curve plasma triglyceride | 0-240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma GLP-1 | Plasma GLP-1 profile | 0-240 minutes | 
| Plasma N-acyl taurine species | Profile of plasma n-acyl taurine species | 0-240 minutes | 
| Plasma ApoB48 | Plasma ApoB48 profile | 0-240 minutes | 
| Satiety, hunger and appetite | 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. | 0-240 minutes | 
| Food intake (g) | Grams consumed of a standard ad libitum meal | t=240 minutes | 
| Food intake (kcal) | kcal consumed of a standard ad libitum meal | t=240 minutes | 
| Plasma triglyceride (TG) distribution | total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG | 0-240 minutes | 
| Plasma free fatty acid species | Total fatty acids profile | 0-240 minutes | 
| Plasma cholesterol | Total cholesterol, HDL, LDL, VLDL, remnant cholesterol | 0-240 minutes | 
| Plasma level of glucose regulating hormones | Insulin, glucagon and gastric inhibitory polypeptide | 0-240 minutes | 
| Plasma amino acids | Total amino acids profile | 0-240 minutes | 
| Plasma glucose | Plasma glucose profile | 0-240 minutes | 
| Plasma bile acid species | Plasma bile acid profile | 0-240 minutes | 
| Gall bladder emptying: Cholecystokinin | Cholecystokinin profile | 0-240 minutes | 
| Gall bladder emptying: Ultrasonography | Difference in volume from most to least full | 0-240 minutes | 
| Gastric emptying: Paracetamol | Plasma acetaminphen profile | 0-240 minutes | 
| Stool quality | Self-assessment of stool quality by the Bristol Stool Scale (1-7, where 1 = most solid and 7 = least solid) | Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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N-acyl taurine