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

Sponsor

University Hospital, Gentofte, Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05953064

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertriglyceridemia	Other: DHA-NAT Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DHA-NAT Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.	Other: DHA-NAT Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid Other Names: C22:6 N-acyl taurine
Placebo Comparator: Placebo Oral administration with a test meal of 55 kJ/kg bodyweight, with 60% of calories from fat.	Other: Placebo Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).

Arm

Intervention/Treatment

Experimental: DHA-NAT

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

Other: DHA-NAT

Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid

Other Names:

C22:6 N-acyl taurine

Placebo Comparator: Placebo

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

Other: Placebo

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

Outcome Measures

Primary Outcome Measures

Plasma triglyceride [0-240 minutes]
Change in incremental area-under-curve plasma triglyceride

Secondary Outcome Measures

Plasma GLP-1 [0-240 minutes]
Plasma GLP-1 profile
Plasma N-acyl taurine species [0-240 minutes]
Profile of plasma n-acyl taurine species
Plasma ApoB48 [0-240 minutes]
Plasma ApoB48 profile
Satiety, hunger and appetite [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.
Food intake (g) [t=240 minutes]
Grams consumed of a standard ad libitum meal
Food intake (kcal) [t=240 minutes]
kcal consumed of a standard ad libitum meal
Plasma triglyceride (TG) distribution [0-240 minutes]
total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG
Plasma free fatty acid species [0-240 minutes]
Total fatty acids profile
Plasma cholesterol [0-240 minutes]
Total cholesterol, HDL, LDL, VLDL, remnant cholesterol
Plasma level of glucose regulating hormones [0-240 minutes]
Insulin, glucagon and gastric inhibitory polypeptide
Plasma amino acids [0-240 minutes]
Total amino acids profile
Plasma glucose [0-240 minutes]
Plasma glucose profile
Plasma bile acid species [0-240 minutes]
Plasma bile acid profile
Gall bladder emptying: Cholecystokinin [0-240 minutes]
Cholecystokinin profile
Gall bladder emptying: Ultrasonography [0-240 minutes]
Difference in volume from most to least full
Gastric emptying: Paracetamol [0-240 minutes]
Plasma acetaminphen profile
Stool quality [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 30 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Clinical Metabolic Research, Herlev-Gentofte Hospital	Hellerup		Denmark	2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Filip Krag Knop, Principal Investigator, Clinical Professor, University Hospital, Gentofte, Copenhagen

ClinicalTrials.gov Identifier:

NCT05953064

Other Study ID Numbers:

FEAST

First Posted:

Jul 19, 2023

Last Update Posted:

Jul 19, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Filip Krag Knop, Principal Investigator, Clinical Professor, University Hospital, Gentofte, Copenhagen

N-acyl taurine

Additional relevant MeSH terms:

Hypertriglyceridemia

Hyperlipidemias

Study Results

No Results Posted as of Jul 19, 2023