Bioavailability of Omega-3 Food Supplements in Healthy Subjects

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376621
• Other study ID #: CTN00714102
• Status: Completed
• Phase: Phase 1
• First received: February 11, 2015
• Last updated: February 25, 2015
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Pronova BioPharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• PronovaPure 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
• Pronovum 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
• Pronovum 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
• PronovaPure 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
• Pronovum 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

Locations

Country	Name	City	State
United Kingdom	Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Pronova BioPharma

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve of omega-3 based dietary supplements under fasted conditions.		Pharmacokinetics up to 36 hours postdose	Yes
Primary	Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.		Pharmacokinetics up to 36 hours postdose	Yes