Dietary Intake of Alpha-linolenic Acid in Elderly

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025620
• Other study ID #: Alphalinolenage
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 18, 2017
• Start date: November 2006
• Est. completion date: December 2011

Study information

• Verified date: January 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: December 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Inflammation
• Lipid Metabolism Disorders
• Metabolic Diseases
• Metabolism Disorder, Lipid

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	hopital Emile Roux	Limeil Brevannes

Sponsors (6)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut Elevage, ITERG, SAINT HUBERT, TERRES INOVIA, TERRES UNIVIA

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Review. — View Citation

Salvà 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	Others	ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)	6 weeks