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

Not Applicable

Active, not recruiting

• Conditions: Hypertriglyceridemia

• 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

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-19
• Primary Completion: 2023-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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
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
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)
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