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Bioavailability of Omega-3 Food Supplements in Healthy Subjects

Nutrition Products - An Open-Label, Randomised, Single-Dose Study to Evaluate the Bioavailability of Omega-3 Based Dietary Supplements Under Fasting Conditions in Healthy Male and Female Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02376621
Enrollment
24
Registered
2015-03-03
Start date
2014-10-31
Completion date
2014-12-31
Last updated
2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

omega-3 based dietary supplements, Bioavailability

Brief summary

The study will evaluate the bioavailability of omega-3 based dietary supplements under fasted conditions in healthy adult subjects. Each subject will participate in 5 treatment periods. The order of treatments will be in accordance with the randomisation schedule.There will be a minimum of 4 treatment-free days between each treatment period. On each dosing occasion, subjects will be fasted for at least 10 hours overnight, prior to the morning of dosing. Twenty-four subjects will be enrolled to complete dosing of 20 subjects.

Interventions

DIETARY_SUPPLEMENTPronovaPure 150:500 triglycerides

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

DIETARY_SUPPLEMENTPronovum PRF-048

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

DIETARY_SUPPLEMENTPronovum PRF-037

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

DIETARY_SUPPLEMENTPronovaPure 500:200 TG

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

DIETARY_SUPPLEMENTPronovum PRF-047

Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE

Sponsors

Pronova BioPharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* males or females * any ethnic origin * age 40 - 65 years * BMI 18.5 - 30.0 kg/m2 * generally in good health * signed informed consent

Exclusion criteria

* males or females not willing to use appropriate contraception * prescribed systemic or topical medication taken within 14 days * taken supplements containing omega-3 faty acids or fish oil last 14 days or any non-prescribed systemic or topical medication including herbal remedies and vitamin/mineral supplements within 7 days * taken any medication including St. John's Worth known to alter drug absorption within 30 days * subjects participating in a clinical study past 3 months * recent blood donation * significant history of drug allergy or any allergic disease * allergy or hypersensitivity to omega-3 fatty acids, fish, soya, oleic acid, sesame oil or other constituents of pharmaceutical preparation. * high consumption of tobacco * high consumption of alcohol * other significant medical history or physical findings (including HIV,hepatitis) * vegetarians * not willing to follow dietary restrictions * frequent migraine attacks * previously taken part in or withdrawn from study or according to investigator should not participate.

Design outcomes

Primary

MeasureTime frame
Area under curve of omega-3 based dietary supplements under fasted conditions.Pharmacokinetics up to 36 hours postdose
Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.Pharmacokinetics up to 36 hours postdose

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026