Status:
COMPLETED
Alpha-Linolenic Acid and Inflammatory Markers
Lead Sponsor:
Harvard School of Public Health (HSPH)
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 ac...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00967733
Start Date
February 1 2009
End Date
August 1 2009
Last Update
December 19 2023
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