Clinical trial NCT05953064: Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects
Official title: Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (FEAST): a Randomised, Double-blind, Placebocontrolled, Crossover Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertriglyceridemia
Keywords: N-acyl taurine
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma triglyceride
timeFrame: 0-240 minutes
Secondary outcomes:
measure: Plasma GLP-1
timeFrame: 0-240 minutes
measure: Plasma N-acyl taurine species
timeFrame: 0-240 minutes
measure: Plasma ApoB48
timeFrame: 0-240 minutes
measure: Satiety, hunger and appetite
timeFrame: 0-240 minutes
measure: Food intake (g)
timeFrame: t=240 minutes
measure: Food intake (kcal)
timeFrame: t=240 minutes
measure: Plasma triglyceride (TG) distribution
timeFrame: 0-240 minutes
measure: Plasma free fatty acid species
timeFrame: 0-240 minutes
measure: Plasma cholesterol
timeFrame: 0-240 minutes
measure: Plasma level of glucose regulating hormones
timeFrame: 0-240 minutes
measure: Plasma amino acids
timeFrame: 0-240 minutes
measure: Plasma glucose
timeFrame: 0-240 minutes
measure: Plasma bile acid species
timeFrame: 0-240 minutes
measure: Gall bladder emptying: Cholecystokinin
timeFrame: 0-240 minutes
measure: Gall bladder emptying: Ultrasonography
timeFrame: 0-240 minutes
measure: Gastric emptying: Paracetamol
timeFrame: 0-240 minutes
measure: Stool quality
timeFrame: Up to 24 hours from ingestion of test meal or until first bowel movement if later than 24 hours.
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Herlev-Gentofte Hospital
Study officials:
References: