Alpha-Linolenic Acid and Inflammatory Markers

NCT00967733 | Completed

• 1 other identifier: P-16261-101
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• Markers of inflammation

  6 weeks

Secondary Outcomes (1)

• Plasma lipids and blood pressure

  6 weeks

Study Arms (4)

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

Interventions

Flaxseed oil-Olive oil DIETARY_SUPPLEMENT

2 or 4 gr per day alpha-linolenic acid pill and olive oil used for cooking

High ALA-Low Linoleic

Olive oil-olive oil DIETARY_SUPPLEMENT

1 gr olive oil pill and olive oil used for cooking

Low ALA-Low Linoleic

Flaxseed oil-sunflower oil DIETARY_SUPPLEMENT

2 or 4 gr per day alpha linolenic acid pill and sunflower oil used for cooking

High ALA-High Linoleic

Olive oil-sunflower oil DIETARY_SUPPLEMENT

1 gr olive oil pill and sunflower oil used for cooking

Low ALA-High Linoleic

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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
• 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)

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Olive Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: February 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 19, 2023

Record last verified: 2023-12