- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967733
Alpha-Linolenic Acid and Inflammatory Markers
Effect of Alpha-Linolenic Acid on Blood Markers of Inflammation
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: High ALA-Low Linoleic
|
2 or 4 gr per day alpha-linolenic acid pill and olive oil used for cooking
|
Placebo Comparator: Low ALA-Low Linoleic
|
1 gr olive oil pill and olive oil used for cooking
|
Active Comparator: High ALA-High Linoleic
|
2 or 4 gr per day alpha linolenic acid pill and sunflower oil used for cooking
|
Placebo Comparator: Low ALA-High Linoleic
|
1 gr olive oil pill and sunflower oil used for cooking
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Markers of inflammation
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Plasma lipids and blood pressure
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-16261-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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