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

Hypertriglyceridemia Clinical Trial

— FEAST  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05953064
• Other study ID #: FEAST
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: November 2023
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 meal.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: April 1, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemias
• Hypertriglyceridemia

Intervention

Other:
• DHA-NAT
Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid
• Placebo
Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research, Herlev-Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma triglyceride	Change in incremental area-under-curve plasma triglyceride	0-240 minutes
Secondary	Plasma GLP-1	Plasma GLP-1 profile	0-240 minutes
Secondary	Plasma N-acyl taurine species	Profile of plasma n-acyl taurine species	0-240 minutes
Secondary	Plasma ApoB48	Plasma ApoB48 profile	0-240 minutes
Secondary	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
Secondary	Food intake (g)	Grams consumed of a standard ad libitum meal	t=240 minutes
Secondary	Food intake (kcal)	kcal consumed of a standard ad libitum meal	t=240 minutes
Secondary	Plasma triglyceride (TG) distribution	total TG, and TG in HDL, LDL and VLDL cholesterol, remnant TG	0-240 minutes
Secondary	Plasma free fatty acid species	Total fatty acids profile	0-240 minutes
Secondary	Plasma cholesterol	Total cholesterol, HDL, LDL, VLDL, remnant cholesterol	0-240 minutes
Secondary	Plasma level of glucose regulating hormones	Insulin, glucagon and gastric inhibitory polypeptide	0-240 minutes
Secondary	Plasma amino acids	Total amino acids profile	0-240 minutes
Secondary	Plasma glucose	Plasma glucose profile	0-240 minutes
Secondary	Plasma bile acid species	Plasma bile acid profile	0-240 minutes
Secondary	Gall bladder emptying: Cholecystokinin	Cholecystokinin profile	0-240 minutes
Secondary	Gall bladder emptying: Ultrasonography	Difference in volume from most to least full	0-240 minutes
Secondary	Gastric emptying: Paracetamol	Plasma acetaminphen profile	0-240 minutes
Secondary	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.