Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 17 for:    linoleic | linolenic acid

Dietary Intake of Alpha-linolenic Acid in Elderly

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03025620
Recruitment Status : Completed
First Posted : January 19, 2017
Last Update Posted : January 19, 2017
Sponsor:
Collaborators:
Institut Elevage
ITERG
SAINT HUBERT
TERRES UNIVIA
TERRES INOVIA
Information provided by (Responsible Party):
Fathi Driss, Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Inflammation Metabolism Disorder, Lipid Dietary Supplement: Rapeseed oil Dietary Supplement: Sunflower oil Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official 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
Study Start Date : November 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Alpha-linolenic acid




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025620


Locations
Layout table for location information
France
hopital Emile Roux
Limeil Brevannes, France, 94450
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut Elevage
ITERG
SAINT HUBERT
TERRES UNIVIA
TERRES INOVIA
Investigators
Layout table for investigator information
Principal Investigator: olivier henry, MD Assistance Publique de Paris. Hopital Emile Roux

Publications:
Layout table for additonal information
Responsible Party: Fathi Driss, Doctor, Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03025620     History of Changes
Other Study ID Numbers: Alphalinolenage
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fathi Driss, Assistance Publique - Hôpitaux de Paris:
Alphalinolenic acid
Lipid cardiovascular risk factors
Inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Metabolic Diseases
Lipid Metabolism Disorders
Inflammation
Cardiovascular Diseases
Pathologic Processes