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

NCT ID: NCT05953064

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-04-01

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.

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

DHA-NAT

Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.

Group Type: EXPERIMENTAL

DHA-NAT

Intervention Type: OTHER

Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid

Placebo

Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).

Interventions

DHA-NAT

Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid

Intervention Type: OTHER

Placebo

Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).

Intervention Type: OTHER

Other Intervention Names

C22:6 N-acyl taurine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Filip Krag Knop

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital

Hellerup, , Denmark

Countries

Denmark

Other Identifiers

FEAST

Identifier Type: -

Identifier Source: org_study_id