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Completed

NCT Number: NCT03025620

Dietary Intake of Alpha-linolenic Acid in Elderly

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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Key information

Conditions

Cardiovascular Diseases Inflammation Lipid Metabolism Disorders Metabolic Diseases Metabolism Disorder, Lipid Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hopital Emile Roux

Limeil-Brévannes, 94450, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rapeseed oil

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.

Other names: Alpha-linolenic acid

Sunflower oil

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.

Other names: Linoleic acid

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Others

    Time frame: 6 weeks

    ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • ITERG
  • Institut Elevage
  • SAINT HUBERT
  • TERRES INOVIA
  • TERRES UNIVIA

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Jan 19, 2017
Registry last updated
Jan 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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