Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects (NCT05953064) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of DHA-NAT on Postprandial Lipidaemia in Healthy Male Subjects
Denmark20 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range18 Years – 30 Years
SexMALE
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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