LDL CholesterolPhase 1/2NCT01028274
Safety and Efficacy of a Natural Health Product in Reducing Cholesterol and Triglyceride Levels.
A Phase 1/2 study testing Investigational Product 1 and Investigational Product 2 in people with LDL Cholesterol and Triglycerides, run by Nordic Pharma, USA at 1 site in Canada.
Trial summary
The purpose of this study is to assess the safety and efficacy of a natural health product among participants with elevated LDL cholesterol and triglyceride levels. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- LDL Cholesterol, Triglycerides
- What is being tested?
- Investigational Product 1 and Investigational Product 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Aug 2010
- Phase
- Phase 1/2
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 30 - 70 years.
- 10-year CAD Risk <10%
- Elevated blood LDL cholesterol in the range of 3.0 to 5.0 mmol/L [equivalent to 117-195 mg/dl].
- have elevated TG levels [1.5/L - 4.0mmol/L, or 134 mg/dl - 356 mg/dl].
Who cannot join
- Adults aged less than 30, or more than 70 years of age
- Adults with a 10-year CAD risk >10%
- Individuals with a pre-existing disease or illness including: heart disease, diabetes, renal disease or cancer
- Individuals taking CYP3A4 inhibitors [including cyclosporine and danazol].
- Individuals taking Statin medications, including: Atorvastatin [brand names: Lipitor®, Caduet®]
- Fluvastatin [brand names: Lescol®, Lescol® XL]
Show all 18Show fewer
- Lovastatin [brand names: Advicor ®, Altocor ®, Altoprev ®, Mevacor ®]
- Pravastatin [brand names: Pravachol® , Pravigard® PAC]
- Rosuvastatin [brand name: Crestor®]
- Simvastatin [brand names: Vytorin®, Zocor ®]
- Individuals with an allergy to fish and/or fish oil, Vitamin E, red yeast rice, coenzyme Q10, soybean oil or any other ingredient in the investigational product [i.e. capsule constituents]
- Individuals who anticipate, or have planned surgery during the course of the trial
- Individuals who are taking any other natural health products, particularly those containing vitamin K, high levels of vitamin E or Coenzyme Q10 [individuals on a 4-week wash-out of NHPs will be permitted]
- Individuals who have consumed fish oil or another type of omega-3 fatty acid supplement one-month prior-to and/or during the course of the study
- Women who are pregnant or breastfeeding
- Individuals with a history of migraines
- Individuals taking blood thinning, or blood pressure medications
- Individuals who have been diagnosed with statin-induced muscle damage (myopathy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial to Assess the Safety and Efficacy of a Combination Red Yeast Rice and Omega-3 (EPA+DHA) to Reduce LDL Cholesterol and Triglyceride Levels in Hypercholesterolemic and Hypertriglyceridemic Subjects.
The purpose of this study is to assess the safety and efficacy of a natural health product among participants with elevated LDL cholesterol and triglyceride levels.
Read the detailed description
Cardiovascular Disease [CVD] is one of the primary causes of illness, disability and death in Canada and in the United States. Hypercholesterolemia and hypertriglyceridemia are significant risk factors for the development of cardiovascular disease.
The investigational product used in this trial, has been specially formulated to help reduce elevated triglycerides and LDL cholesterol levels, and may provide a natural alternative in the prevention of CVD.
This study is a prospective, 12 week study, where participants will be randomized to receive the treatment, placebo, or a comparator product for a period of 12 weeks. Blood lipids will be analysed at baseline, week 6 and week 12.
- Conditions
- LDL Cholesterol, Triglycerides
- Being tested
- Placebo, Investigational Product 1, Investigational Product 2
- Keywords
- Hypercholesterolemia, Hypertriglyceridemia, Fish Oil, Red Yeast Rice
- Medical subject headings
- Hypercholesterolemia, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Also called Soybean Oil, Mfr. Product Code: 31237-NNM
Two capsules, twice daily with meals for 12 weeks.
Investigational Product 1Dietary supplement
Also called Mfr. Product Code: 31214-NNM
Two capsules, twice daily with meals for 12 weeks.
Investigational Product 2Dietary supplement
Also called Mfr. Product Code: 31236-NNM
Two capsules, twice daily with meals for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Investigational Product 1 | Experimental | Not described Receives: Dietary Supplement: Investigational Product 1 |
| Investigational Product 2 | Experimental | Not described Receives: Dietary Supplement: Investigational Product 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in LDL levels
Measured: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes (1)
Reduction in TG levels
Measured: 0 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LDL CholesterolStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 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
- Maggie Laidlaw, Ph.D. Candidate, Study director, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.Brad West, ND, Study chair, Nordic NaturalsSteven Traplin, MD, Principal investigator, Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01028274
- Sponsor's protocol ID
- NN-91109
- Other IDs
- NHPD145265
- Status last verified
- Dec 2015
- First submitted
- 8 Dec 2009
- Last updated
- 14 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Safety and Efficacy of a Combination Red Yeast Rice and Omega-3 (EPA+DHA) to Reduce LDL Cholesterol and Triglyceride Levels in Hypercholesterolemic and Hypertriglyceridemic Subjects.
- ClinicalTrials.gov ID
- NCT01028274
- Acronym / sponsor ID
- NN-91109
- Conditions
- LDL Cholesterol, Triglycerides
- Keywords
- Hypercholesterolemia, Hypertriglyceridemia, Fish Oil, Red Yeast Rice
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Nordic Pharma, USAIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Dec 2009 (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 purpose of this study is to assess the safety and efficacy of a natural health product among participants with elevated LDL cholesterol and triglyceride levels.
Detailed description
Cardiovascular Disease [CVD] is one of the primary causes of illness, disability and death in Canada and in the United States. Hypercholesterolemia and hypertriglyceridemia are significant risk factors for the development of cardiovascular disease.
The investigational product used in this trial, has been specially formulated to help reduce elevated triglycerides and LDL cholesterol levels, and may provide a natural alternative in the prevention of CVD.
This study is a prospective, 12 week study, where participants will be randomized to receive the treatment, placebo, or a comparator product for a period of 12 weeks. Blood lipids will be analysed at baseline, week 6 and week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
| Investigational Product 1 | Experimental | Dietary Supplement: Investigational Product 1 |
| Investigational Product 2 | Experimental | Dietary Supplement: Investigational Product 2 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 30 - 70 years.
- 10-year CAD Risk <10%
- Elevated blood LDL cholesterol in the range of 3.0 to 5.0 mmol/L [equivalent to 117-195 mg/dl].
- have elevated TG levels [1.5/L - 4.0mmol/L, or 134 mg/dl - 356 mg/dl].
Key exclusion criteria (18 listed)
- Adults aged less than 30, or more than 70 years of age
- Adults with a 10-year CAD risk >10%
- Individuals with a pre-existing disease or illness including: heart disease, diabetes, renal disease or cancer
- Individuals taking CYP3A4 inhibitors [including cyclosporine and danazol].
- Individuals taking Statin medications, including: Atorvastatin [brand names: Lipitor®, Caduet®]
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 |
|---|---|---|
| PlaceboAlso: Soybean Oil, Mfr. Product Code: 31237-NNMTwo capsules, twice daily with meals for 12 weeks. | Dietary supplement | Placebo |
| Investigational Product 1Also: Mfr. Product Code: 31214-NNMTwo capsules, twice daily with meals for 12 weeks. | Dietary supplement | Investigational Product 1 |
| Investigational Product 2Also: Mfr. Product Code: 31236-NNMTwo capsules, twice daily with meals for 12 weeks. | Dietary supplement | Investigational Product 2 |
Primary outcome
Reduction in LDL levels
Time frame: 0 weeks, 6 weeks, 12 weeks
1 secondary outcome
Reduction in TG levels
Time frame: 0 weeks, 6 weeks, 12 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 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.
Maggie Laidlaw, Ph.D. Candidate study director
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Brad West, ND study chair
Nordic Naturals
Steven Traplin, 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 1/2 study testing Investigational Product 1 and Investigational Product 2 in people with LDL Cholesterol and Triglycerides, 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 4 inclusion and 18 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 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Reduction in LDL levels (time frame: 0 weeks, 6 weeks, 12 weeks). 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 2015.