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Completed NCT07771309

Study of Metabolic Absorption Rates of DHA-Taurine as a Source of Omega-3 Fatty Acids

Conditions: Omega-3 Fatty Acids, Absorption of Omega-3, Pharmacokinetics

Sex: Male
Ages: 18 Years – 30 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 6
Sponsor: University of Copenhagen

Location: Department of Biomedical Sciences, University of Copenhagen Copenhagen

Summary

* Omega-3 fatty acids such as docosahexaenoic acid (DHA) have well-established health benefits and are widely used to improve cardiometabolic health. However, conventional DHA supplements require normal digestion and absorption of dietary fat, which may limit their effectiveness in individuals with impaired fat absorption or those consuming very low-fat diets. * This study investigates the absorption of a novel DHA-containing molecule, DHA-taurine (DHA-T), compared with a conventional DHA ethyl ester (DHA-EE) supplement. Preclinical studies suggest that DHA-T may be absorbed through a different mechanism that is less dependent on normal fat digestion and may therefore provide a more effective way of delivering DHA. * The primary objective is to compare plasma DHA concentrations following administration of DHA-T and DHA-EE under fasting conditions without a meal. The study also evaluates plasma DHA-T concentrations to improve understanding of the absorption, transport, and metabolism of DHA-T in humans. * This is a randomized, double-blind, crossover study in seven healthy male volunteers aged 18 to 30 years. Each participant receives both study interventions in random order, separated by an approximately two-week washout period, allowing each participant to serve as his own control. On each study day, participants undergo repeated blood sampling and ultrasound measurements of gallbladder volume over an 8-hour absorption test following administration of the assigned study intervention. * The results of this study will improve understanding of the absorption and metabolism of DHA-T and may support the future development of omega-3 formulations that are effective even when normal fat absorption is impaired.

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 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/hyperlipidaemia * 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 \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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07771309). StuddyBuddy aggregates publicly available trial information.