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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Other: DHA-NAT; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma triglyceride	Change in incremental area-under-curve plasma triglyceride	0-240 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma GLP-1	Plasma GLP-1 profile	0-240 minutes
Plasma N-acyl taurine species	Profile of plasma n-acyl taurine species	0-240 minutes
Plasma ApoB48	Plasma ApoB48 profile	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.	0-240 minutes
Food intake (g)	Grams consumed of a standard ad libitum meal	t=240 minutes
Food intake (kcal)	kcal consumed of a standard ad libitum meal	t=240 minutes
Plasma triglyceride (TG) distribution	total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG	0-240 minutes
Plasma free fatty acid species	Total fatty acids profile	0-240 minutes
Plasma cholesterol	Total cholesterol, HDL, LDL, VLDL, remnant cholesterol	0-240 minutes
Plasma level of glucose regulating hormones	Insulin, glucagon and gastric inhibitory polypeptide	0-240 minutes
Plasma amino acids	Total amino acids profile	0-240 minutes
Plasma glucose	Plasma glucose profile	0-240 minutes
Plasma bile acid species	Plasma bile acid profile	0-240 minutes
Gall bladder emptying: Cholecystokinin	Cholecystokinin profile	0-240 minutes
Gall bladder emptying: Ultrasonography	Difference in volume from most to least full	0-240 minutes
Gastric emptying: Paracetamol	Plasma acetaminphen profile	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)	Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours.

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): October 31, 2023
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: N-acyl taurine
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Hypertriglyceridemia; Hyperlipidemias
• Other Study ID Numbers: FEAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No