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Dietary Intake of Alpha-linolenic Acid in Elderly

Primary Purpose

Cardiovascular Diseases, Inflammation, Metabolism Disorder, Lipid

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rapeseed oil
Sunflower oil
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiovascular Diseases focused on measuring Alphalinolenic acid, Lipid cardiovascular risk factors, Inflammation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • hopital Emile Roux

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Sunflower arm

Rapeseed arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period
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

Pulse wave velocity (PWV)
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.
Others
ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)

Full Information

First Posted
January 10, 2017
Last Updated
January 18, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut Elevage, ITERG, SAINT HUBERT, TERRES UNIVIA, TERRES INOVIA
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1. Study Identification

Unique Protocol Identification Number
NCT03025620
Brief Title
Dietary Intake of Alpha-linolenic Acid in Elderly
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut Elevage, ITERG, SAINT HUBERT, TERRES UNIVIA, TERRES INOVIA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Inflammation, Metabolism Disorder, Lipid
Keywords
Alphalinolenic acid, Lipid cardiovascular risk factors, Inflammation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunflower arm
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Rapeseed arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Rapeseed oil
Other Intervention Name(s)
Alpha-linolenic acid
Intervention Description
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
Intervention Name(s)
Sunflower oil
Other Intervention Name(s)
Linoleic acid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Pulse wave velocity (PWV)
Description
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.
Time Frame
6 weeks
Title
Others
Description
ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
olivier henry, MD
Organizational Affiliation
Assistance Publique de Paris. Hopital Emile Roux
Official's Role
Principal Investigator
Facility Information:
Facility Name
hopital Emile Roux
City
Limeil Brevannes
ZIP/Postal Code
94450
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20667934
Citation
Giallauria F, Vigorito C, Tramarin R, Fattirolli F, Ambrosetti M, De Feo S, Griffo R, Riccio C, Piepoli M; ISYDE-2008 Investigators of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Prevention. Cardiac rehabilitation in very old patients: data from the Italian Survey on Cardiac Rehabilitation-2008 (ISYDE-2008)--official report of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Epidemiology. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1353-61. doi: 10.1093/gerona/glq138. Epub 2010 Jul 28.
Results Reference
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PubMed Identifier
21076723
Citation
Rodriguez-Leyva D, Dupasquier CM, McCullough R, Pierce GN. The cardiovascular effects of flaxseed and its omega-3 fatty acid, alpha-linolenic acid. Can J Cardiol. 2010 Nov;26(9):489-96. doi: 10.1016/s0828-282x(10)70455-4.
Results Reference
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PubMed Identifier
15304539
Citation
Salva A, Corman B, Andrieu S, Salas J, Vellas B; International Association Of Gerontology/International Academy Of Nutrition And Aging Task Force. Minimum data set for nutritional intervention studies in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):724-9. doi: 10.1093/gerona/59.7.m724.
Results Reference
background
PubMed Identifier
16799140
Citation
Bischoff HA, Staehelin HB, Willett WC. The effect of undernutrition in the development of frailty in older persons. J Gerontol A Biol Sci Med Sci. 2006 Jun;61(6):585-9. doi: 10.1093/gerona/61.6.585. No abstract available.
Results Reference
background
PubMed Identifier
19196012
Citation
Abbatecola AM, Cherubini A, Guralnik JM, Andres Lacueva C, Ruggiero C, Maggio M, Bandinelli S, Paolisso G, Ferrucci L. Plasma polyunsaturated fatty acids and age-related physical performance decline. Rejuvenation Res. 2009 Feb;12(1):25-32. doi: 10.1089/rej.2008.0799.
Results Reference
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Dietary Intake of Alpha-linolenic Acid in Elderly

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