Hypertriglyceridemia
Conditions
Keywords
N-acyl taurine
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.
Interventions
OTHERDHA-NAT
Endogenous metabolite of omega-3 fatty acid docosahexaenoic acid
OTHERPlacebo
Vehicle control (H2O) for the intervention used in the experimental arm (DHA-NAT).
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 30 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma triglyceride | 0-240 minutes | Change in incremental area-under-curve plasma triglyceride |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 GLP-1 | 0-240 minutes | Plasma GLP-1 profile |
| 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) |
| Plasma level of glucose regulating hormones | 0-240 minutes | Insulin, glucagon and gastric inhibitory polypeptide |
Countries
Denmark
Outcome results
None listed