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Active, Not Recruiting

NCT Number: NCT05953064

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA-NAT

Other

Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid

Other names: C22:6 N-acyl taurine

Placebo

Other

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

Primary outcomes

  1. Plasma triglyceride

    Time frame: 0-240 minutes

    Change in incremental area-under-curve plasma triglyceride

Secondary outcomes

  1. Plasma GLP-1

    Time frame: 0-240 minutes

    Plasma GLP-1 profile

  2. Plasma N-acyl taurine species

    Time frame: 0-240 minutes

    Profile of plasma n-acyl taurine species

  3. Plasma ApoB48

    Time frame: 0-240 minutes

    Plasma ApoB48 profile

  4. Satiety, hunger and appetite

    Time frame: 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.

  5. Food intake (g)

    Time frame: t=240 minutes

    Grams consumed of a standard ad libitum meal

  6. Food intake (kcal)

    Time frame: t=240 minutes

    kcal consumed of a standard ad libitum meal

  7. Plasma triglyceride (TG) distribution

    Time frame: 0-240 minutes

    total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG

  8. Plasma free fatty acid species

    Time frame: 0-240 minutes

    Total fatty acids profile

  9. Plasma cholesterol

    Time frame: 0-240 minutes

    Total cholesterol, HDL, LDL, VLDL, remnant cholesterol

  10. Plasma level of glucose regulating hormones

    Time frame: 0-240 minutes

    Insulin, glucagon and gastric inhibitory polypeptide

  11. Plasma amino acids

    Time frame: 0-240 minutes

    Total amino acids profile

  12. Plasma glucose

    Time frame: 0-240 minutes

    Plasma glucose profile

  13. Plasma bile acid species

    Time frame: 0-240 minutes

    Plasma bile acid profile

  14. Gall bladder emptying: Cholecystokinin

    Time frame: 0-240 minutes

    Cholecystokinin profile

  15. Gall bladder emptying: Ultrasonography

    Time frame: 0-240 minutes

    Difference in volume from most to least full

  16. Gastric emptying: Paracetamol

    Time frame: 0-240 minutes

    Plasma acetaminphen profile

  17. Stool quality

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

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

Acronym: FEAST

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Jul 19, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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