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

NCT05953064 | Active Not Recruiting DMC

• 1 other identifier: FEAST
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

N-acyl taurine

Outcome Measures

Primary Outcomes (1)

• Plasma triglyceride

  Change in incremental area-under-curve plasma triglyceride

  0-240 minutes

Secondary Outcomes (17)

• Plasma GLP-1

  0-240 minutes

• Plasma N-acyl taurine species

  0-240 minutes

• Plasma ApoB48

  0-240 minutes

• Satiety, hunger and appetite

  0-240 minutes

• Food intake (g)

  t=240 minutes

Study Arms (2)

DHA-NAT

EXPERIMENTAL

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

Other: DHA-NAT

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

DHA-NAT OTHER

Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid

Also known as: C22:6 N-acyl taurine

DHA-NAT

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 19, 2023
• Study Start: January 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: April 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)