NCT03025620

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

4.3 years

First QC Date

January 10, 2017

Last Update Submit

January 18, 2017

Conditions

Cardiovascular DiseasesInflammationMetabolism Disorder, Lipid

Keywords

Alphalinolenic acidLipid cardiovascular risk factorsInflammation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Pulse wave velocity (PWV)

    6 weeks

  • Others

    6 weeks

Study Arms (2)

Sunflower arm

PLACEBO COMPARATOR

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

Rapeseed arm

ACTIVE COMPARATOR

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

Interventions

Rapeseed oilDIETARY_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.

Also known as: Alpha-linolenic acid
Rapeseed arm
Sunflower oilDIETARY_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.

Also known as: Linoleic acid
Sunflower arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients unable to understand the objectives of the dietary intervention
  • Patients in paliative care
  • Patients receiving supplement diets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hopital Emile Roux

Limeil-Brévannes, 94450, France

Location

Related Publications (5)

  • 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.

    PMID: 20667934BACKGROUND

  • 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.

    PMID: 21076723BACKGROUND

  • 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.

    PMID: 15304539BACKGROUND

  • 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.

    PMID: 16799140BACKGROUND

  • 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.

    PMID: 19196012BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesInflammationLipid Metabolism Disorders

Interventions

Rapeseed Oilalpha-Linolenic AcidSunflower OilLinoleic Acid

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant OilsOilsLipidsPlant PreparationsBiological ProductsComplex MixturesFatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLinolenic AcidsFatty Acids, EssentialFatty Acids, UnsaturatedFatty AcidsLinoleic AcidsFatty Acids, Omega-6

Study Officials

  • olivier henry, MD

    Assistance Publique de Paris. Hopital Emile Roux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 19, 2017

Study Start

November 1, 2006

Primary Completion

February 1, 2011

Study Completion

December 1, 2011

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)