HyperlipidemiaNCT01671254
Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
A study testing FishOil, CBE75 and CBE150 in people with Hyperlipidemia, run by MetaProteomics LLC at 1 site in United States.
Trial summary
The purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- FishOil, CBE75 and CBE150
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2012
- Phase
- Interventional
- 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 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women ≥ 18 and ≤ 72 years old
- generally healthy
- BMI > 18 and < 38
- LDL cholesterol ≥ 130 mg/dl and < 270 mg/dl
- triglycerides ≥ 150 mg/dl and < 400 mg/dl
- ability to understand and the willingness to sign a written informed consent
Who cannot join
- use of nutritional supplements and medical foods for dyslipidemia within 30 days prior to the study
- use of omega-3 fatty acid dietary supplements within 30 days prior to the study
- use of prescription HMG-CoA reductase inhibitors, bile acid sequestrants, fibrates, cholesterol absorption blocking agents, or niacin
- use of prescription medications and/or nonprescription medications for acute and semi-acute medical conditions
- history of cardiovascular disease, type i diabetes, autoimmune disease, liver or kidney disease, malignancy, and serious mental illness.
- known infection with HIB, TB, hepatitis B or hepatitis C
Show all 9Show fewer
- history of allergy or intolerance to study products
- smoking, use of nicotine-containing products, or use of drugs of abuse 30 days prior to the study
- history of regular intake of > 14 alcoholic drinks per week for females and > 21 drinks per week for males
Trial locations and contacts
1 site in 1 country.
United States1 site
Functional Medicine Research Center
Gig Harbor, Washington, 98332
About this study
Official title: A Double-blind, Placebo-controlled Trial of a Dietary Supplement Containing Citrus Bioflavonoids and Vitamin E at 2 Doses in Conjunction With Fish Oil Supplementation in Hyperlipidemic Subjects
The purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects
- Conditions
- Hyperlipidemia
- Being tested
- FishOil, CBE75, CBE150, placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FishOilDietary supplement
CBE75Dietary supplement
CBE150Dietary supplement
placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| FishOil + placebo | Active comparator | Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule Receives: Dietary Supplement: FishOil; Dietary Supplement: placebo |
| FishOil + CBE75 | Experimental | Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day) Receives: Dietary Supplement: FishOil; Dietary Supplement: CBE75 |
| FishOil + CBE150 | Experimental | Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day) Receives: Dietary Supplement: FishOil; Dietary Supplement: CBE150 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Change in LDL cholesterol level at the end of 8 weeks
Measured: Baseline, 8 weeks
Secondary outcomes (4)
Triglyceride
Change in triglyceride level at the end of 8 weeks.
Measured: Baseline, 8 weeks
oxLDL
Change in oxidized LDL level at the end of 8 weeks.
Measured: Baseline, 8 weeks
Total cholesterol
Change in total cholesterol level at the end of 8 weeks.
Measured: Baseline, 8 weeks
HDL cholesterol
Change in HDL cholesterol level at the end of 8 weeks.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetaProteomics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph J Lamb, MD, Principal investigator, MetaProteomics / Metagenics / FMRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671254
- Sponsor's protocol ID
- POT2-FMR-CT
- Status last verified
- May 2018
- First submitted
- 20 Aug 2012
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled Trial of a Dietary Supplement Containing Citrus Bioflavonoids and Vitamin E at 2 Doses in Conjunction With Fish Oil Supplementation in Hyperlipidemic Subjects
- ClinicalTrials.gov ID
- NCT01671254
- Acronym / sponsor ID
- POT2-FMR-CT
- Conditions
- Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MetaProteomics LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Aug 2012 (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 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FishOil + placebo | Active comparator | Dietary Supplement: FishOil, Dietary Supplement: placeboSubjects in this arm receive fish oil (EPA/DHA Extra Strength) and placebo capsule |
| FishOil + CBE75 | Experimental | Dietary Supplement: FishOil, Dietary Supplement: CBE75Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and citrus bioflavonoids+vitamin E (CBE)(75 mg/capsule/day) |
| FishOil + CBE150 | Experimental | Dietary Supplement: FishOil, Dietary Supplement: CBE150Subjects in this arm receive fish oil (EPA/DHA Extra Strength) and CBE (150 mg/capsule/day) |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- men and women ≥ 18 and ≤ 72 years old
- generally healthy
- BMI > 18 and < 38
- LDL cholesterol ≥ 130 mg/dl and < 270 mg/dl
- triglycerides ≥ 150 mg/dl and < 400 mg/dl
Key exclusion criteria (9 listed)
- use of nutritional supplements and medical foods for dyslipidemia within 30 days prior to the study
- use of omega-3 fatty acid dietary supplements within 30 days prior to the study
- use of prescription HMG-CoA reductase inhibitors, bile acid sequestrants, fibrates, cholesterol absorption blocking agents, or niacin
- use of prescription medications and/or nonprescription medications for acute and semi-acute medical conditions
- history of cardiovascular disease, type i diabetes, autoimmune disease, liver or kidney disease, malignancy, and serious mental illness.
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 |
|---|---|---|
| FishOil | Dietary supplement | FishOil + CBE150, FishOil + CBE75, FishOil + placebo |
| CBE75 | Dietary supplement | FishOil + CBE75 |
| CBE150 | Dietary supplement | FishOil + CBE150 |
| placebo | Dietary supplement | FishOil + placebo |
Primary outcome
LDL cholesterol
Time frame: Baseline, 8 weeks
Change in LDL cholesterol level at the end of 8 weeks
4 secondary outcomes
Triglyceride
Time frame: Baseline, 8 weeks
oxLDL
Time frame: Baseline, 8 weeks
Total cholesterol
Time frame: Baseline, 8 weeks
HDL cholesterol
Time frame: Baseline, 8 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 18 May 2018.
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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.
Joseph J Lamb, MD principal investigator
MetaProteomics / Metagenics / FMRC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FishOil, CBE75 and CBE150 in people with Hyperlipidemia, run by MetaProteomics LLC at 1 site in United States.
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 9 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 18 May 2018. 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 States. 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.
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?
LDL cholesterol (time frame: Baseline, 8 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 18 May 2018.