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

University Hospital, Gentofte, Copenhagen

Status: Active, not recruiting

Conditions: Hypertriglyceridemia

Treatments: Other: Placebo; Other: DHA-NAT

Study type: Interventional

Funder types: Other

Identifiers

NCT05953064

FEAST

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

DHA-NAT

Experimental group

Description:

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

Treatment:

Other: DHA-NAT

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo