Dietary Intake of Alpha-linolenic Acid in Elderly

January 18, 2017 updated by: Fathi Driss, Assistance Publique - Hôpitaux de Paris

Investigation of the Relationship Between Alpha-linolenic Acid and Arterial, Biochemical, Biological Parameters in Older Persons With History of Cardiovascular Events and/or Moderate Cognitive Impairment

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limeil Brevannes, France, 94450
        • Hôpital Emile Roux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • Patients unable to understand the objectives of the dietary intervention
  • Patients in paliative care
  • Patients receiving supplement diets

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
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.
Other Names:
  • Linoleic acid
Active Comparator: 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.
Dietary supplement: 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.
Other Names:
  • Alpha-linolenic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period
Time Frame: 6 weeks
Blood samples have been done at the beginning and at the end of the dietary period. Fatty acids analyses of the red cells and serum have been performed by GC method.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse wave velocity (PWV)
Time Frame: 6 weeks

Pulse wave velocity values have been performed at the beginning and the end of the dietary period.

The purpose was to evaluate the relationship between PWV and dietary intakes of ALA.
6 weeks
Others
Time Frame: 6 weeks
ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

ITERG
Institut Elevage
SAINT HUBERT
TERRES UNIVIA
TERRES INOVIA

Investigators

  • Principal Investigator: olivier henry, MD, Assistance Publique de Paris. Hopital Emile Roux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alphalinolenage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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