Dietary Intake of Alpha-linolenic Acid in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-12-31

Brief Summary

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The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential of an adequate intake of alpha-linolenic acid in elderly.

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Detailed Description

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There is growing evidence that diets high in long chain n-3 polyunsaturated fatty acids (PUFA) decrease the risk of fatal ischemic heart disease.Both epidemiologic studies and clinical trials demonstrate substantial cardioprotective effects of alpha linolenic acid (ALA) from vegetable oils.However, little is known about the relation of the dietary intake of ALA with ischemic heart disease among older adults.In this study, elderly volunteers will be asked to ingest a supplement of a vegetable oil providing 1g of ALA, or an equivalent amount of linoleic acid as sunflower oil, for a diet period of 6 weeks.Serum samples will be collected before the dietary intervention and 6 weeks later.Plasma biomarkers of inflammatory, lipid cardiovascular risk factors and serum and red cell membrane fatty acid composition will be determined on all samples.

Conditions

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Cardiovascular Diseases Inflammation Metabolism Disorder, Lipid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sunflower arm

Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of sunflower oil (with a high content in linoleic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with sunflower oil (60% fat) that replaced butter on the breakfast toasts.

Group Type PLACEBO_COMPARATOR

Sunflower oil

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator arm : Dietary Supplement: sunflower oil supplementation (10g per day) and margarine with a high level of inoleic acid (12.5g per day) during 42 days.

Rapeseed arm

Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of rapeseed oil (with a high content in alpha-linolenic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with rapeseed oil (60% fat) that replaced butter on the breakfast toasts.

Group Type ACTIVE_COMPARATOR

Rapeseed oil

Intervention Type DIETARY_SUPPLEMENT

Active comparator arm : Dietary Supplement: rapeseed oil supplementation (10g per day) and margarine with a high level of alpha-linolenic acid (12.5g per day) during 42 days.

Interventions

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Rapeseed oil

Active comparator arm : Dietary Supplement: rapeseed oil supplementation (10g per day) and margarine with a high level of alpha-linolenic acid (12.5g per day) during 42 days.

Intervention Type DIETARY_SUPPLEMENT

Sunflower oil

Placebo comparator arm : Dietary Supplement: sunflower oil supplementation (10g per day) and margarine with a high level of inoleic acid (12.5g per day) during 42 days.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Alpha-linolenic acid Linoleic acid

Eligibility Criteria

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Inclusion Criteria

* Elderly patients over 65 years old exhibiting clinical indices of cardiovascular disease
* Male or female
* Subjects who were hospitalized in the Geriatric Unit of the Emile Roux Hospital (AP-HP)
* MMSE (Mini Mental State Examination)score \> or = 15
* Supervision available for study medication
* Able to ingest oral diet