Healthy VolunteersPhase 2NCT02628483
A Comparator Trial on the Relative Efficacy of Two Triglyceride Forms of Fish Oil
A Phase 2 study testing Fish Oil in people with Healthy Volunteers, run by Nordic Pharma, USA at 1 site in Canada.
Trial summary
The health benefits of omega-3 fatty acids have been extensively examined in many published studies, and these benefits have been observed in patients with a diversity of conditions and diseases, including cardiovascular disease (e.g. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2016
- Phase
- Phase 2
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults aged 18 - 35 (inclusive)
- Healthy as determined from medical history
- Non-smoker, or ex-smoker ≥6 months
- Body mass index 18.5 - 24.9 kg/m2
- Female participants of childbearing potential (i.e. not surgically sterilized or post-menopausal greater than one year) must have negative urine pregnancy test and must be using an effective birth control method
- Willing to avoid alcohol consumption for 24 h prior to every clinic visit
- Willing to maintain a stable body weight, activity level and dietary pattern except for use of the study products, as directed
- Willing and able to provide informed written consent
Who cannot join
- Individuals taking prescription or non-prescription health products that may affect the study endpoint (e.g. corticosteroids, prescription anti-inflammatory drugs, blood lipid-lowering drugs (e.g. statins, fibrates, bile acid exchanger resin, phytosterols, niacin or its analogues, carnitine, etc.) in the previous 6 months
- Individuals taking any supplements with omega-3 fatty acids, phytosterols, polyglucosamines (Chitosan) or other lipid-binding ingredients in the previous 6 months
- Individuals who consume omega-3 fatty acid rich fish (salmon, mackerel, herring) more than twice per month
- Unstable use (initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1
- Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 6 months prior to visit 1 and throughout the study
- Pregnancy or lactation, or participant unwilling to take appropriate contraceptives for the duration of the study
Show all 19Show fewer
- History of blood clotting disorders or use of coagulation-inhibiting drugs (e.g. warfarin)
- Presence of major diseases such as diabetes, gastrointestinal, endocrine, cardiovascular, renal, or liver disease
- History of neurological disease (e.g. Parkinson's disease, stroke, traumatic brain injury, etc.)
- History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in past 5 years
- Uncontrolled hypertension defined as a seated resting systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
- Abnormal laboratory test results of clinical significance, including, but not limited to, ALT or AST ≥1.5X the upper limit of normal at screening (visit 1)
- Triglycerides ≥400 mg/dL (≥4.52mmol/L) at screening (visit 1)
- Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day
- Participant has a known allergy or intolerance to fish/fish oil or any of the ingredients in the test products
- Participant is vegan
- Participant is unwilling or unable to abide by the requirements of the protocol
- Any condition that would interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study, or put the participant at risk
- Participant has taken an investigational medicine or has participated in a research study within 30 days prior to the first study visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel Clinical Trial to Compare the Relative Efficacy of Two Triglyceride Forms of Fish Oil, Ultimate Omega®, and a Comparator Product, in Improving Red Blood Cell Fatty Acid Profiles in Healthy Adults (FORCE Study)
The health benefits of omega-3 fatty acids have been extensively examined in many published studies, and these benefits have been observed in patients with a diversity of conditions and diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis, thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline, periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to healthy individuals, in terms of preventative health benefits. The balance between omega-6 long chain fatty acids and their omega-3 counterparts is important in health maintenance. An omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014 study of the dietary habits of U.S. adults revealed that, in general, North Americans do not meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to be considered, in order to help this population meet their daily needs. Both the Academy of Nutrition and Dietetics and the American Heart Association suggest a prudent approach in recommending an increased intake of omega-3 fatty acids. Although both organisations recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also recognise that supplementation may also be required in order to meet target values, particularly in at-risk populations.
Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA and DHA and are available in varying forms including ethyl ester and high triglyceride forms. Differences in product formulation have been shown to have varying health effects.
- Conditions
- Healthy Volunteers
- Being tested
- Fish Oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish OilDietary supplement
Also called Ultimate Omega
1000mg fish oil per capsule (325mg EPA + 225mg DHA)
Fish OilDietary supplement
Also called Meg-3
1000mg fish oil per capsule (300mg EPA + 200mg DHA)
| Study group | Role | What they receive |
|---|---|---|
| Ultimate Omega | Experimental | 5 capsules of Ultimate Omega fish oil daily in the morning with food Receives: Dietary Supplement: Fish Oil |
| Meg-3 | Active comparator | 5 capsules of Meg-3 fish oil daily in the morning with food Receives: Dietary Supplement: Fish Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell EPA and DHA
Measured: 24 weeks
Phospholipid EPA and DHA
Measured: 4 weeks
Secondary outcomes (2)
Red blood cell EPA and DHA
Measured: 12 and 16 weeks
Lipid profile
Total cholesterol, LDL-C, HDL-C and triglycerides
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Pharma, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Anthony Bier, MD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628483
- Sponsor's protocol ID
- 1007-008-PRO-040414
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2015
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel Clinical Trial to Compare the Relative Efficacy of Two Triglyceride Forms of Fish Oil, Ultimate Omega®, and a Comparator Product, in Improving Red Blood Cell Fatty Acid Profiles in Healthy Adults (FORCE Study)
- ClinicalTrials.gov ID
- NCT02628483
- Acronym / sponsor ID
- 1007-008-PRO-040414
- Conditions
- Healthy Volunteers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nordic Pharma, USAIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Dec 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 health benefits of omega-3 fatty acids have been extensively examined in many published studies, and these benefits have been observed in patients with a diversity of conditions and diseases, including cardiovascular disease (e.g. atrial fibrillation, atherosclerosis, thrombosis, inflammation, sudden cardiac death, etc.), age-related cognitive decline, periodontal disease, rheumatoid arthritis, etc. These fatty acids may also be beneficial to healthy individuals, in terms of preventative health benefits. The balance between omega-6 long chain fatty acids and their omega-3 counterparts is important in health maintenance. An omega-6:omega-3 ratio of 1:1 or 2:1 is recommended for optimal health, yet the average ratio in the North American population is estimated to be as much as 10:1 or even 20:1. A 2014 study of the dietary habits of U.S. adults revealed that, in general, North Americans do not meet the recommended omega-3 fatty acid intake from foods alone. Supplementation may need to be considered, in order to help this population meet their daily needs. Both the Academy of Nutrition and Dietetics and the American Heart Association suggest a prudent approach in recommending an increased intake of omega-3 fatty acids. Although both organisations recommend a preference for obtaining omega-3 fatty acids through fish consumption, both also recognise that supplementation may also be required in order to meet target values, particularly in at-risk populations.
Several omega-3 fish oil supplements exist on the market each with their own ratios of EPA and DHA and are available in varying forms including ethyl ester and high triglyceride forms. Differences in product formulation have been shown to have varying health effects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultimate Omega | Experimental | Dietary Supplement: Fish Oil5 capsules of Ultimate Omega fish oil daily in the morning with food |
| Meg-3 | Active comparator | Dietary Supplement: Fish Oil5 capsules of Meg-3 fish oil daily in the morning with food |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female adults aged 18 - 35 (inclusive)
- Healthy as determined from medical history
- Non-smoker, or ex-smoker ≥6 months
- Body mass index 18.5 - 24.9 kg/m2
- Female participants of childbearing potential (i.e. not surgically sterilized or post-menopausal greater than one year) must have negative urine pregnancy test and must be using an effective birth control method
Key exclusion criteria (19 listed)
- Individuals taking prescription or non-prescription health products that may affect the study endpoint (e.g. corticosteroids, prescription anti-inflammatory drugs, blood lipid-lowering drugs (e.g. statins, fibrates, bile acid exchanger resin, phytosterols, niacin or its analogues, carnitine, etc.) in the previous 6 months
- Individuals taking any supplements with omega-3 fatty acids, phytosterols, polyglucosamines (Chitosan) or other lipid-binding ingredients in the previous 6 months
- Individuals who consume omega-3 fatty acid rich fish (salmon, mackerel, herring) more than twice per month
- Unstable use (initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to visit 1
- Use of any weight-loss programs or weight-loss medications (prescription or over-the counter) including, but not limited to, lipase inhibitors, within 6 months prior to visit 1 and throughout the study
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 |
|---|---|---|
| Fish OilAlso: Ultimate Omega1000mg fish oil per capsule (325mg EPA + 225mg DHA) | Dietary supplement | Ultimate Omega |
| Fish OilAlso: Meg-31000mg fish oil per capsule (300mg EPA + 200mg DHA) | Dietary supplement | Meg-3 |
Primary outcome
Red blood cell EPA and DHA
Time frame: 24 weeks
Phospholipid EPA and DHA
Time frame: 4 weeks
2 secondary outcomes
Red blood cell EPA and DHA
Time frame: 12 and 16 weeks
Lipid profile
Time frame: 24 weeks
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 14 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Anthony Bier, MD principal investigator
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish Oil in people with Healthy Volunteers, run by Nordic Pharma, USA at 1 site in Canada.
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 8 inclusion and 19 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 14 Dec 2016. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Red blood cell EPA and DHA (time frame: 24 weeks). 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 14 Dec 2016.