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Completed

NCT Number: NCT02376621

Bioavailability of Omega-3 Food Supplements in Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • previously taken part in or withdrawn from study or according to investigator should not participate.

Treatment and study plan

PronovaPure 150:500 triglycerides

Dietary Supplement

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

Pronovum PRF-048

Dietary Supplement

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

Pronovum PRF-037

Dietary Supplement

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

PronovaPure 500:200 TG

Dietary Supplement

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

Pronovum PRF-047

Dietary Supplement

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

Primary outcomes

  1. Area under curve of omega-3 based dietary supplements under fasted conditions.

    Time frame: Pharmacokinetics up to 36 hours postdose

  2. Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.

    Time frame: Pharmacokinetics up to 36 hours postdose

Sponsors and collaborators

Lead sponsor

Pronova BioPharma

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 3, 2015
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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