Clinical trial NCT03025620: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Inflammation
Metabolism Disorder, Lipid
Keywords: Alphalinolenic acid
Lipid cardiovascular risk factors
Inflammation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut Elevage
name: ITERG
name: SAINT HUBERT
name: TERRES UNIVIA
name: TERRES INOVIA
First posted: 2017-01-19
Enrollment: 254
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period
timeFrame: 6 weeks
Secondary outcomes:
measure: Pulse wave velocity (PWV)
timeFrame: 6 weeks
measure: Others
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Limeil Brevannes
country: France
facility: hopital Emile Roux
Study officials:
affiliation: Assistance Publique de Paris. Hopital Emile Roux
name: olivier henry, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.