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

NCT07771309 | Completed

• 2 other identifiers: H-25014363NNF21OC0067271
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Omega-3 Fatty Acids; Absorption of Omega-3; Pharmacokinetics

Keywords

DHA-taurine; Omega-3 fatty acids; Pharmacokinetics; Crossover study; Docosahexaenoic acid

Outcome Measures

Primary Outcomes (1)

• Plasma DHA

  Measurements of plasma DHA as iAUC 0-480 minute, Peak level and Time to peak (minute). Plasma DHA is measured in μg/mL.

  0-480 minute

Secondary Outcomes (3)

• Plasma DHA-T

  0-480 minutes

• NAT species, besides DHA-T

  0-480 minutes

• Bile acids (total and individual species)

  0-480 minutes

Other Outcomes (10)

• Glucose

  0-480 minutes

• Triglyceride (TG) distribution (total triglycerides, and in HDL, LDL and VLDL cholesterol, remnant fractions)

  0-480 minutes

• Non-esterified fatty acids (NEFA) (total and individual species)

  0-480 minutes

Study Arms (2)

DHA-EE Followed by DHA-T

EXPERIMENTAL

Participants were randomized to receive a single oral dose of DHA ethyl ester (DHA-EE) on the first study day followed by a single oral dose of DHA-taurine (DHA-T) on the second study day after an approximately two-week washout period.

Dietary Supplement: DHA-taurine; Dietary Supplement: DHA ethyl ester

DHA-T Followed by DHA-EE

EXPERIMENTAL

Participants were randomized to receive a single oral dose of DHA-taurine (DHA-T) on the first study day followed by a single oral dose of DHA ethyl ester (DHA-EE) on the second study day after an approximately two-week washout period.

Dietary Supplement: DHA-taurine; Dietary Supplement: DHA ethyl ester

Interventions

DHA-taurine DIETARY_SUPPLEMENT

Weight-adjusted oral administration of DHA-taurine (2 mg/kg) under fasting conditions. Participants received a single dose on one study visit as part of a randomized, double-blind crossover design. Plasma DHA and DHA-taurine concentrations were measured during an 8-hour absorption test.

DHA-EE Followed by DHA-T; DHA-T Followed by DHA-EE

DHA ethyl ester DIETARY_SUPPLEMENT

Weight-adjusted oral administration of DHA ethyl ester (1.637 mg/kg, equimolar DHA content to 2 mg/kg DHA-taurine) under fasting conditions. Participants received a single dose on one study visit as part of a randomized, double-blind crossover design. Plasma DHA concentrations were measured during an 8-hour absorption test.

DHA-EE Followed by DHA-T; DHA-T Followed by DHA-EE

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Healthy
• Age between 18 and 30 years
• Body mass index between 18.5-25 kg/m2
• Informed consent
• Moderate level of physical activity

You may not qualify if:

• 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 \<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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Department of Biomedical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

Location

Study Officials

• Trisha J Grevengoed, PhD

  University of Copenhagen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 18, 2026
• Study Start: April 15, 2025
• Primary Completion: August 19, 2025
• Study Completion: October 29, 2025
• Last Updated: August 18, 2026

Record last verified: 2026-07

Locations

DK (1)