ClinicalTrials.gg
CompletedNCT05953064FEASTUpdated Sep 21, 2026

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

An interventional study of DHA-NAT and Placebo in Hypertriglyceridemia, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2023, registered Jun 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Hypertriglyceridemia

Browse trials for

Keywords

  • N-acyl taurine
03

In context

Hypertriglyceridemia

324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.

This study's enrollment of 20 is below the median of 66 across 288 interventional studies indexed under Hypertriglyceridemia.

Browse Hypertriglyceridemia studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 162 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male
  • Healthy
  • Age between 18 and 30 years
  • between 18.5-25 kg/m2
  • Moderate level of physical activity assessed with IPAQ (short version)

Exclusion criteria

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 (HbA1c) >48 mmol/mol, familial hypercholesterolemia/hyperlipidemia
  • Anaemia ( below 8.3 mmol/L)
  • (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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    DHA-NAT

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

    Other: DHA-NAT

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • OtherDHA-NAT

    Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid

    Also known as: C22:6 N-acyl taurine

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. Plasma triglyceride

    Change in incremental area-under-curve plasma triglyceride

    Time frame: 0-240 minutes

Secondary outcomes

  1. Plasma GLP-1

    Plasma GLP-1 profile

    Time frame: 0-240 minutes

  2. Plasma N-acyl taurine species

    Profile of plasma n-acyl taurine species

    Time frame: 0-240 minutes

  3. Plasma ApoB48

    Plasma ApoB48 profile

    Time frame: 0-240 minutes

  4. Satiety, hunger and appetite

    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.

    Time frame: 0-240 minutes

  5. Food intake (g)

    Grams consumed of a standard ad libitum meal

    Time frame: t=240 minutes

  6. Food intake (kcal)

    kcal consumed of a standard ad libitum meal

    Time frame: t=240 minutes

  7. Plasma triglyceride (TG) distribution

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

    Time frame: 0-240 minutes

  8. Plasma free fatty acid species

    Total fatty acids profile

    Time frame: 0-240 minutes

  9. Plasma cholesterol

    Total cholesterol, HDL, LDL, VLDL, remnant cholesterol

    Time frame: 0-240 minutes

  10. Plasma level of glucose regulating hormones

    Insulin, glucagon and gastric inhibitory polypeptide

    Time frame: 0-240 minutes

  11. Plasma amino acids

    Total amino acids profile

    Time frame: 0-240 minutes

  12. Plasma glucose

    Plasma glucose profile

    Time frame: 0-240 minutes

  13. Plasma bile acid species

    Plasma bile acid profile

    Time frame: 0-240 minutes

  14. Gall bladder emptying: Cholecystokinin

    Cholecystokinin profile

    Time frame: 0-240 minutes

  15. Gall bladder emptying: Ultrasonography

    Difference in volume from most to least full

    Time frame: 0-240 minutes

  16. Gastric emptying: Paracetamol

    Plasma acetaminphen profile

    Time frame: 0-240 minutes

  17. Stool quality

    Self-assessment of stool quality by the Bristol Stool Scale (1-7, where 1 = most solid and 7 = least solid)

    Time frame: Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours.

07

Study locations

1 site
  • Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
    Hellerup, 2900, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2023 to primary completion in Oct 2023, 9 months.

Of 42 non-industry interventional studies with no phase under Hypertriglyceridemia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 39. This study's 9 months is below that.

Counting every sponsor, half of 45 studies reached it within 23 months; a quarter within 7 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2023
First posted
Jul 19, 2023
StartActual
Jan 1, 2023
Primary completionActual
Oct 31, 2023
CompletionActual
Oct 31, 2023
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05953064
Responsible party
Filip Krag Knop (Principal Investigator, Clinical Professor, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Jul 19, 2023
Start date
Jan 1, 2023
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023
Last update
Sep 21, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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