HealthyPhase 1NCT02376621
Bioavailability of Omega-3 Food Supplements in Healthy Subjects
A Phase 1 study testing PronovaPure 150:500 triglycerides, Pronovum PRF-048 and Pronovum PRF-037 in people with Healthy, run by Pronova BioPharma at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PronovaPure 150:500 triglycerides, Pronovum PRF-048 and Pronovum PRF-037
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males or females
- any ethnic origin
- age 40 - 65 years
- BMI 18.5 - 30.0 kg/m2
- generally in good health
- signed informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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- previously taken part in or withdrawn from study or according to investigator should not participate.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical research Unit (CRU) Ltd,Springfield House, Hyde street
Leeds, LS2 9LH
About this study
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
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.
- Conditions
- Healthy
- Being tested
- PronovaPure 150:500 triglycerides, Pronovum PRF-048, Pronovum PRF-037, PronovaPure 500:200 TG, Pronovum PRF-047
- Keywords
- omega-3 based dietary supplements, Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PronovaPure 150:500 triglyceridesDietary 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-048Dietary 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-037Dietary 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 TGDietary 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-047Dietary 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
| Study group | Role | What they receive |
|---|---|---|
| PronovaPure 150:500 triglycerides | Active comparator | 3 × PronovaPure 150:500 triglycerides (TG) European Union (EU) Receives: Dietary Supplement: PronovaPure 150:500 triglycerides; Dietary Supplement: Pronovum PRF-048; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: PronovaPure 500:200 TG; Dietary Supplement: Pronovum PRF-047 |
| Pronovum PRF-048 | Active comparator | 3 × Pronovum PRF-048 Receives: Dietary Supplement: PronovaPure 150:500 triglycerides; Dietary Supplement: Pronovum PRF-048; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: PronovaPure 500:200 TG; Dietary Supplement: Pronovum PRF-047 |
| Pronovum PRF-037 | Active comparator | 3 × Pronovum PRF-037 Receives: Dietary Supplement: PronovaPure 150:500 triglycerides; Dietary Supplement: Pronovum PRF-048; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: PronovaPure 500:200 TG; Dietary Supplement: Pronovum PRF-047 |
| PronovaPure 500:200 TG | Active comparator | 3 × PronovaPure 500:200 TG EU Receives: Dietary Supplement: PronovaPure 150:500 triglycerides; Dietary Supplement: Pronovum PRF-048; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: PronovaPure 500:200 TG; Dietary Supplement: Pronovum PRF-047 |
| Pronovum PRF-047 | Active comparator | 3 × Pronovum PRF-047 Receives: Dietary Supplement: PronovaPure 150:500 triglycerides; Dietary Supplement: Pronovum PRF-048; Dietary Supplement: Pronovum PRF-037; Dietary Supplement: PronovaPure 500:200 TG; Dietary Supplement: Pronovum PRF-047 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve of omega-3 based dietary supplements under fasted conditions.
Measured: Pharmacokinetics up to 36 hours postdose
Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.
Measured: Pharmacokinetics up to 36 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Brooks, MD, Principal investigator, Covance Clinical Research Unit (CRU) Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376621
- Sponsor's protocol ID
- CTN00714102
- Status last verified
- Feb 2015
- First submitted
- 11 Feb 2015
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02376621
- Acronym / sponsor ID
- CTN00714102
- Conditions
- Healthy
- Keywords
- omega-3 based dietary supplements, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PronovaPure 150:500 triglycerides | Active comparator | Dietary Supplement: PronovaPure 150:500 triglycerides, Dietary Supplement: Pronovum PRF-048, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: PronovaPure 500:200 TG, Dietary Supplement: Pronovum PRF-0473 × PronovaPure 150:500 triglycerides (TG) European Union (EU) |
| Pronovum PRF-048 | Active comparator | Dietary Supplement: PronovaPure 150:500 triglycerides, Dietary Supplement: Pronovum PRF-048, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: PronovaPure 500:200 TG, Dietary Supplement: Pronovum PRF-0473 × Pronovum PRF-048 |
| Pronovum PRF-037 | Active comparator | Dietary Supplement: PronovaPure 150:500 triglycerides, Dietary Supplement: Pronovum PRF-048, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: PronovaPure 500:200 TG, Dietary Supplement: Pronovum PRF-0473 × Pronovum PRF-037 |
| PronovaPure 500:200 TG | Active comparator | Dietary Supplement: PronovaPure 150:500 triglycerides, Dietary Supplement: Pronovum PRF-048, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: PronovaPure 500:200 TG, Dietary Supplement: Pronovum PRF-0473 × PronovaPure 500:200 TG EU |
| Pronovum PRF-047 | Active comparator | Dietary Supplement: PronovaPure 150:500 triglycerides, Dietary Supplement: Pronovum PRF-048, Dietary Supplement: Pronovum PRF-037, Dietary Supplement: PronovaPure 500:200 TG, Dietary Supplement: Pronovum PRF-0473 × Pronovum PRF-047 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- males or females
- any ethnic origin
- age 40 - 65 years
- BMI 18.5 - 30.0 kg/m2
- generally in good health
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PronovaPure 150:500 triglyceridesSubjects 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 supplement | PronovaPure 150:500 triglycerides, PronovaPure 500:200 TG, Pronovum PRF-037, Pronovum PRF-047, Pronovum PRF-048 |
| Pronovum PRF-048Subjects 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 supplement | PronovaPure 150:500 triglycerides, PronovaPure 500:200 TG, Pronovum PRF-037, Pronovum PRF-047, Pronovum PRF-048 |
| Pronovum PRF-037Subjects 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 supplement | PronovaPure 150:500 triglycerides, PronovaPure 500:200 TG, Pronovum PRF-037, Pronovum PRF-047, Pronovum PRF-048 |
| PronovaPure 500:200 TGSubjects 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 supplement | PronovaPure 150:500 triglycerides, PronovaPure 500:200 TG, Pronovum PRF-037, Pronovum PRF-047, Pronovum PRF-048 |
| Pronovum PRF-047Subjects 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 supplement | PronovaPure 150:500 triglycerides, PronovaPure 500:200 TG, Pronovum PRF-037, Pronovum PRF-047, Pronovum PRF-048 |
Primary outcome
Area under curve of omega-3 based dietary supplements under fasted conditions.
Time frame: Pharmacokinetics up to 36 hours postdose
Peak plasma concentration of omega-3 based dietary supplements under fasted conditions.
Time frame: Pharmacokinetics up to 36 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashley Brooks, MD principal investigator
Covance Clinical Research Unit (CRU) Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PronovaPure 150:500 triglycerides, Pronovum PRF-048 and Pronovum PRF-037 in people with Healthy, run by Pronova BioPharma at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve of omega-3 based dietary supplements under fasted conditions. (time frame: Pharmacokinetics up to 36 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2015.