Cardiovascular DiseaseNCT00967733
Alpha-Linolenic Acid and Inflammatory Markers
A study testing Flaxseed oil-Olive oil, Olive oil-olive oil and Flaxseed oil-sunflower oil in people with Cardiovascular Disease, run by Harvard School of Public Health (HSPH).
Trial summary
The optimal type of oil to prevent cardiovascular disease (CVD) is uncertain. In general, unsaturated oils with higher content of cis-monounsaturated fatty acids (MONO) or cis-polyunsaturated fatty acids (PUFA) are preferable over those rich in saturated fatty acids. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Flaxseed oil-Olive oil, Olive oil-olive oil and Flaxseed oil-sunflower oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Aug 2009
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50 or older at time of enrollment
- Willing to cook and eat foods prepared exclusively with the study oils and nothing else every day of the week at least 2 meals per day for 24 weeks
- Willing to eat no more than one meal per week prepared out of the home
- Willingness to take 4 or 8 capsules with ALA or placebo every day for 24 weeks
- Willingness to provide personal and next of kin address and phone number for follow-up visits to the home.
- Willingness to complete measurement procedures and blood draws.
- Ability and willingness to provide informed consent to be screened and to take part of the study.
Who cannot join
- Medication Exclusions
- Unstable dose of medications during the past 2 months that raise or lower blood pressure, lipids or glucose. Unstable dose is a dose change in the past 6 months or less than 6 months of treatment.
- Medical History Exclusions
- Active or prior CVD (stroke, MI, PTCA, CABG, congestive heart failure, symptomatic ischemic heart disease (angina), or CVD-related therapeutic procedure).
- Cancer diagnosis or treatment in past two years (however, persons with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy)
- Active inflammatory bowel disease, malabsorption, or major GI resection
Show all 17Show fewer
- Chronic renal disease
- Any serious illness not otherwise specified that would interfere with participation
- Stage 2 hypertension (SBP > 160 or DBP > 100 mmHg) based on the mean of 3 measurements on the screening visit, as well as a systolic BP > 170 or diastolic BP > 105 at any of the measurements
- Other Exclusions
- Eat fish more than once per week including canned fish
- Significant oil preferences, intolerances, dietary habits, or dietary requirements that would interfere with adherence
- Planning to leave the area for more than two weeks prior to the anticipated end of participation
- Current participation in another study that manipulates diet or that will affect the outcome of this study
- Taking vitamin, vegetable oil, fish-oil, weight-loss, soy, mineral, or herbal supplements that cannot be stopped
- Unable to measure blood pressure (due to arm circumference > 50 cm)
- Investigator judgment (e.g. for concerns over adherence, or follow-up or for inappropriate behavior)
About this study
Official title: Effect of Alpha-Linolenic Acid on Blood Markers of Inflammation
The optimal type of oil to prevent cardiovascular disease (CVD) is uncertain. In general, unsaturated oils with higher content of cis-monounsaturated fatty acids (MONO) or cis-polyunsaturated fatty acids (PUFA) are preferable over those rich in saturated fatty acids. However, unsaturated oils can vary in their relative contents of n-6 and n-3 fatty acids (specifically alpha-linolenic acid (ALA)). Some investigators advocate that oils rich in ALA are cardioprotective, while others suggest that optimal cardioprotective effects can only be obtained when oils are lower in n-6 fatty acids (mainly linoleic acid) in addition to being higher in ALA. It is hypothesized that increased ALA would result in beneficial effects on inflammatory markers. The objective of this trial is to establish definitively the biological effects of ALA with and without reductions in linoleic acid on inflammatory markers linked to CVD.
Read the detailed description
This study is a dietary trial that examines the effects of increasing ALA by 2 gr or 4 gr per day, with and without decreasing linoleic acid, on inflammatory markers linked to CVD. Trial participants (n=136), approximately 50% women, 50% men) are age 50 and older and living in the town of Montana, Bulgaria during the study. The study uses a double-blinded placebo-controlled, randomized cross-over design. Combinations of two oils that are considered healthy (sunflower and olive) and an ALA supplement containing either 2 or 4 gr of ALA (supplied as flaxseed oil) or placebo are consumed for 6 weeks each: sunflower-ALA (high linoleic-low ALA), sunflower-placebo (high linoleic-low ALA), olive-ALA (low-linoleic-high ALA) and olive-placebo (low linoleic-low ALA). The participants are indicated to keep their usual diet and physical activity through-out the study. The primary endpoints are plasma levels of inflammatory markers. Secondary endpoints include systolic and diastolic blood pressure, and plasma levels of LDL cholesterol, HDL cholesterol and triglycerides.
SPECIFIC AIMS
To determine the effect of increasing ALA by 2 or 4 gr per day in the context of a diet that that is high in linoleic acid (~13% energy) on inflammatory markers. The ALA effect will be tested by comparing ALA supplement vs. placebo while using sunflower oil for cooking at home. We hypothesize that ALA has favorable effects on inflammatory markers in the context of a diet that is high in linoleic acid.
To determine the effect of increasing ALA by 2 or 4 gr per day in the context of a diet that that is low in linoleic acid (~6% energy) on inflammatory markers. The ALA effect will be tested by comparing ALA supplement vs. placebo while using olive oil for cooking at home. We hypothesize that ALA has favorable effects on inflammatory markers in the context of a diet that is low in linoleic acid.
SECONDARY AIMS
To determine the effect of reducing linoleic acid from a high level (~13% energy) to a low level (~6% energy) while keeping ALA at a high level (2 or 4 gr per day) on plasma levels of inflammatory markers. The reduction in linoleic acid will be tested by comparing sunflower to olive oil while taking the ALA supplement. We hypothesize that reducing linoleic acid does not affect inflammatory markers when ALA intake is high.
To determine the effect of reducing linoleic acid from a high level (~13% energy) to a low level (~6% energy) while keeping ALA at a low level (placebo) on plasma levels of inflammatory markers. The reduction in linoleic acid will be tested by comparing sunflower to olive oil while taking the placebo. We hypothesize that reducing linoleic acid does not affect inflammatory markers when ALA intake is low.
To determine whether the intervention contrasts specified in the specific aims and secondary aims 1 \& 2 affect plasma levels of LDL cholesterol, HDL cholesterol and triglycerides and blood pressure.
We hypothesize that ALA has favorable effects on plasma triglycerides and blood pressure compared to placebo regardless of whether linoleic acid is high or low.
We hypothesize that lowering linoleic acid has favorable effects on plasma HDL cholesterol but unfavorable effects on LDL cholesterol,regardless of whether ALA is high or low.
- Conditions
- Cardiovascular Disease
- Being tested
- Flaxseed oil-Olive oil, Olive oil-olive oil, Flaxseed oil-sunflower oil, Olive oil-sunflower oil
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flaxseed oil-Olive oilDietary supplement
2 or 4 gr per day alpha-linolenic acid pill and olive oil used for cooking
Olive oil-olive oilDietary supplement
1 gr olive oil pill and olive oil used for cooking
Flaxseed oil-sunflower oilDietary supplement
2 or 4 gr per day alpha linolenic acid pill and sunflower oil used for cooking
Olive oil-sunflower oilDietary supplement
1 gr olive oil pill and sunflower oil used for cooking
| Study group | Role | What they receive |
|---|---|---|
| High ALA-Low Linoleic | Active comparator | Not described Receives: Dietary Supplement: Flaxseed oil-Olive oil |
| Low ALA-Low Linoleic | Placebo comparator | Not described Receives: Dietary Supplement: Olive oil-olive oil |
| High ALA-High Linoleic | Active comparator | Not described Receives: Dietary Supplement: Flaxseed oil-sunflower oil |
| Low ALA-High Linoleic | Placebo comparator | Not described Receives: Dietary Supplement: Olive oil-sunflower oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of inflammation
Measured: 6 weeks
Secondary outcomes (1)
Plasma lipids and blood pressure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967733
- Sponsor's protocol ID
- P-16261-101
- Status last verified
- Dec 2023
- First submitted
- 27 Aug 2009
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alpha-Linolenic Acid on Blood Markers of Inflammation
- ClinicalTrials.gov ID
- NCT00967733
- Acronym / sponsor ID
- P-16261-101
- Conditions
- Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- Feb 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 28 Aug 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 optimal type of oil to prevent cardiovascular disease (CVD) is uncertain. In general, unsaturated oils with higher content of cis-monounsaturated fatty acids (MONO) or cis-polyunsaturated fatty acids (PUFA) are preferable over those rich in saturated fatty acids. However, unsaturated oils can vary in their relative contents of n-6 and n-3 fatty acids (specifically alpha-linolenic acid (ALA)). Some investigators advocate that oils rich in ALA are cardioprotective, while others suggest that optimal cardioprotective effects can only be obtained when oils are lower in n-6 fatty acids (mainly linoleic acid) in addition to being higher in ALA. It is hypothesized that increased ALA would result in beneficial effects on inflammatory markers. The objective of this trial is to establish definitively the biological effects of ALA with and without reductions in linoleic acid on inflammatory markers linked to CVD.
Detailed description
This study is a dietary trial that examines the effects of increasing ALA by 2 gr or 4 gr per day, with and without decreasing linoleic acid, on inflammatory markers linked to CVD. Trial participants (n=136), approximately 50% women, 50% men) are age 50 and older and living in the town of Montana, Bulgaria during the study. The study uses a double-blinded placebo-controlled, randomized cross-over design. Combinations of two oils that are considered healthy (sunflower and olive) and an ALA supplement containing either 2 or 4 gr of ALA (supplied as flaxseed oil) or placebo are consumed for 6 weeks each: sunflower-ALA (high linoleic-low ALA), sunflower-placebo (high linoleic-low ALA), olive-ALA (low-linoleic-high ALA) and olive-placebo (low linoleic-low ALA). The participants are indicated to keep their usual diet and physical activity through-out the study. The primary endpoints are plasma levels of inflammatory markers. Secondary endpoints include systolic and diastolic blood pressure, and plasma levels of LDL cholesterol, HDL cholesterol and triglycerides.
SPECIFIC AIMS
To determine the effect of increasing ALA by 2 or 4 gr per day in the context of a diet that that is high in linoleic acid (~13% energy) on inflammatory markers. The ALA effect will be tested by comparing ALA supplement vs. placebo while using sunflower oil for cooking at home. We hypothesize that ALA has favorable effects on inflammatory markers in the context of a diet that is high in linoleic acid.
To determine the effect of increasing ALA by 2 or 4 gr per day in the context of a diet that that is low in linoleic acid (~6% energy) on inflammatory markers. The ALA effect will be tested by comparing ALA supplement vs. placebo while using olive oil for cooking at home. We hypothesize that ALA has favorable effects on inflammatory markers in the context of a diet that is low in linoleic acid.
SECONDARY AIMS
To determine the effect of reducing linoleic acid from a high level (~13% energy) to a low level (~6% energy) while keeping ALA at a high level (2 or 4 gr per day) on plasma levels of inflammatory markers. The reduction in linoleic acid will be tested by comparing sunflower to olive oil while taking the ALA supplement. We hypothesize that reducing linoleic acid does not affect inflammatory markers when ALA intake is high.
To determine the effect of reducing linoleic acid from a high level (~13% energy) to a low level (~6% energy) while keeping ALA at a low level (placebo) on plasma levels of inflammatory markers. The reduction in linoleic acid will be tested by comparing sunflower to olive oil while taking the placebo. We hypothesize that reducing linoleic acid does not affect inflammatory markers when ALA intake is low.
To determine whether the intervention contrasts specified in the specific aims and secondary aims 1 \& 2 affect plasma levels of LDL cholesterol, HDL cholesterol and triglycerides and blood pressure.
We hypothesize that ALA has favorable effects on plasma triglycerides and blood pressure compared to placebo regardless of whether linoleic acid is high or low.
We hypothesize that lowering linoleic acid has favorable effects on plasma HDL cholesterol but unfavorable effects on LDL cholesterol,regardless of whether ALA is high or low.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High ALA-Low Linoleic | Active comparator | Dietary Supplement: Flaxseed oil-Olive oil |
| Low ALA-Low Linoleic | Placebo comparator | Dietary Supplement: Olive oil-olive oil |
| High ALA-High Linoleic | Active comparator | Dietary Supplement: Flaxseed oil-sunflower oil |
| Low ALA-High Linoleic | Placebo comparator | Dietary Supplement: Olive oil-sunflower oil |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 50 or older at time of enrollment
- Willing to cook and eat foods prepared exclusively with the study oils and nothing else every day of the week at least 2 meals per day for 24 weeks
- Willing to eat no more than one meal per week prepared out of the home
- Willingness to take 4 or 8 capsules with ALA or placebo every day for 24 weeks
- Willingness to provide personal and next of kin address and phone number for follow-up visits to the home.
Key exclusion criteria (17 listed)
- Medication Exclusions
- Unstable dose of medications during the past 2 months that raise or lower blood pressure, lipids or glucose. Unstable dose is a dose change in the past 6 months or less than 6 months of treatment.
- Medical History Exclusions
- Active or prior CVD (stroke, MI, PTCA, CABG, congestive heart failure, symptomatic ischemic heart disease (angina), or CVD-related therapeutic procedure).
- Cancer diagnosis or treatment in past two years (however, persons with non-melanoma skin cancer, localized breast cancer, or localized prostate cancer can enroll if they did not require systemic chemotherapy)
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 |
|---|---|---|
| Flaxseed oil-Olive oil2 or 4 gr per day alpha-linolenic acid pill and olive oil used for cooking | Dietary supplement | High ALA-Low Linoleic |
| Olive oil-olive oil1 gr olive oil pill and olive oil used for cooking | Dietary supplement | Low ALA-Low Linoleic |
| Flaxseed oil-sunflower oil2 or 4 gr per day alpha linolenic acid pill and sunflower oil used for cooking | Dietary supplement | High ALA-High Linoleic |
| Olive oil-sunflower oil1 gr olive oil pill and sunflower oil used for cooking | Dietary supplement | Low ALA-High Linoleic |
Primary outcome
Markers of inflammation
Time frame: 6 weeks
1 secondary outcome
Plasma lipids and blood pressure
Time frame: 6 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 19 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Flaxseed oil-Olive oil, Olive oil-olive oil and Flaxseed oil-sunflower oil in people with Cardiovascular Disease, run by Harvard School of Public Health (HSPH).
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 7 inclusion and 17 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Markers of inflammation (time frame: 6 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 19 Dec 2023.