HypertriglyceridemiaFEASTNCT05953064
Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects
A study testing DHA-NAT in people with Hypertriglyceridemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- DHA-NAT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2023to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
Hellerup, 2900
About this study
Official title: Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (FEAST): a Randomised, Double-blind, Placebocontrolled, Crossover Study
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
- Being tested
- DHA-NAT, Placebo
- Keywords
- N-acyl taurine
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHA-NATOther
Also called C22:6 N-acyl taurine
Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid
PlaceboOther
Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).
| Study group | Role | What they receive |
|---|---|---|
| DHA-NAT | Experimental | Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. Receives: Other: DHA-NAT |
| Placebo | Placebo comparator | Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma triglyceride
Change in incremental area-under-curve plasma triglyceride
Measured: 0-240 minutes
Secondary outcomes (17)
Plasma GLP-1
Plasma GLP-1 profile
Measured: 0-240 minutes
Plasma N-acyl taurine species
Profile of plasma n-acyl taurine species
Measured: 0-240 minutes
Plasma ApoB48
Plasma ApoB48 profile
Measured: 0-240 minutes
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.
Measured: 0-240 minutes
Food intake (g)
Grams consumed of a standard ad libitum meal
Measured: t=240 minutes
Food intake (kcal)
kcal consumed of a standard ad libitum meal
Measured: t=240 minutes
Plasma triglyceride (TG) distribution
total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG
Measured: 0-240 minutes
Plasma free fatty acid species
Total fatty acids profile
Measured: 0-240 minutes
Plasma cholesterol
Total cholesterol, HDL, LDL, VLDL, remnant cholesterol
Measured: 0-240 minutes
Plasma level of glucose regulating hormones
Insulin, glucagon and gastric inhibitory polypeptide
Measured: 0-240 minutes
Plasma amino acids
Total amino acids profile
Measured: 0-240 minutes
Plasma glucose
Plasma glucose profile
Measured: 0-240 minutes
Plasma bile acid species
Plasma bile acid profile
Measured: 0-240 minutes
Gall bladder emptying: Cholecystokinin
Cholecystokinin profile
Measured: 0-240 minutes
Gall bladder emptying: Ultrasonography
Difference in volume from most to least full
Measured: 0-240 minutes
Gastric emptying: Paracetamol
Plasma acetaminphen profile
Measured: 0-240 minutes
Stool quality
Self-assessment of stool quality by the Bristol Stool Scale (1-7, where 1 = most solid and 7 = least solid)
Measured: Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Jan 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953064
- Sponsor's protocol ID
- FEAST
- Acronym
- FEAST
- Status last verified
- Sep 2026
- First submitted
- 20 Jun 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (FEAST): a Randomised, Double-blind, Placebocontrolled, Crossover Study
- ClinicalTrials.gov ID
- NCT05953064
- Acronym / sponsor ID
- FEAST / FEAST
- Conditions
- Hypertriglyceridemia
- Keywords
- N-acyl taurine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA-NAT | Experimental | Other: DHA-NATOral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. |
| Placebo | Placebo comparator | Other: PlaceboOral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- Healthy
- Age between 18 and 30 years
- Body mass index between 18.5-25 kg/m2
- Informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHA-NATAlso: C22:6 N-acyl taurineEndogenous metabolite of omega-3 fatty acid docosahexaenoic acid | Other | DHA-NAT |
| PlaceboVehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT). | Other | Placebo |
Primary outcome
Plasma triglyceride
Time frame: 0-240 minutes
Change in incremental area-under-curve plasma triglyceride
17 secondary outcomes
Plasma GLP-1
Time frame: 0-240 minutes
Plasma N-acyl taurine species
Time frame: 0-240 minutes
Plasma ApoB48
Time frame: 0-240 minutes
Satiety, hunger and appetite
Time frame: 0-240 minutes
Food intake (g)
Time frame: t=240 minutes
Food intake (kcal)
Time frame: t=240 minutes
Plasma triglyceride (TG) distribution
Time frame: 0-240 minutes
Plasma free fatty acid species
Time frame: 0-240 minutes
Plasma cholesterol
Time frame: 0-240 minutes
Plasma level of glucose regulating hormones
Time frame: 0-240 minutes
Plasma amino acids
Time frame: 0-240 minutes
Plasma glucose
Time frame: 0-240 minutes
Plasma bile acid species
Time frame: 0-240 minutes
Gall bladder emptying: Cholecystokinin
Time frame: 0-240 minutes
Gall bladder emptying: Ultrasonography
Time frame: 0-240 minutes
Gastric emptying: Paracetamol
Time frame: 0-240 minutes
Stool quality
Time frame: Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHA-NAT in people with Hypertriglyceridemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma triglyceride (time frame: 0-240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.