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Spermidine Intake and All-cause Mortality

NCT ID: NCT03378843

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

829 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-10-31

Study Completion Date

2015-10-31

Brief Summary

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This study seeks to test the potential association between spermidine content in diet and mortality in humans.

Detailed Description

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This prospective community-based cohort study includes 829 participants aged 45-84 years, 49.9% of which are male. Diet is assessed by repeated dietician-administered validated food-frequency questionnaires (2540 assessments) in 1995, 2000, 2005, and 2010. Nutrient intakes including spermidine are calculated using USDA standard databases. Clinical events (all-cause mortality and cause-specific mortality) are recorded from 1995 to 2015.

The primary endpoint of all-cause mortality is related to the exposure of long-term average spermidine intake by Cox proportional hazards models with time-varying covariates. Additional analyses employ the Fine and Gray proportional subdistribution hazards model and flexible Royston-Parmar spline-based models. Comprehensive sensitivity analyses are performed to guard against potential biases associated with nutritional epidemiology.

Conditions

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Healthy Diet Mortality

Keywords

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Polyamine, cardiovascular disease, cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Spermidine content of natural diet

The exposure consists in the long-term average dietary intake of the polyamine spermidine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Resident of Bruneck aged 40-79 years in 1990, age- and sex-stratified random sample.
Minimum Eligible Age

45 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Krankenhaus Bruneck

OTHER

Sponsor Role collaborator

University of Graz

OTHER

Sponsor Role collaborator

Paracelsus Medical University

OTHER

Sponsor Role collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role collaborator

Universitaet Innsbruck

OTHER

Sponsor Role collaborator

Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Stefan Kiechl

A.Univ.-Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Kiechl, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Innsbruck

References

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Kiechl S, Lorenz E, Reindl M, Wiedermann CJ, Oberhollenzer F, Bonora E, Willeit J, Schwartz DA. Toll-like receptor 4 polymorphisms and atherogenesis. N Engl J Med. 2002 Jul 18;347(3):185-92. doi: 10.1056/NEJMoa012673.

Reference Type BACKGROUND
PMID: 12124407 (View on PubMed)

Stegemann C, Pechlaner R, Willeit P, Langley SR, Mangino M, Mayr U, Menni C, Moayyeri A, Santer P, Rungger G, Spector TD, Willeit J, Kiechl S, Mayr M. Lipidomics profiling and risk of cardiovascular disease in the prospective population-based Bruneck study. Circulation. 2014 May 6;129(18):1821-31. doi: 10.1161/CIRCULATIONAHA.113.002500. Epub 2014 Mar 12.

Reference Type BACKGROUND
PMID: 24622385 (View on PubMed)

Pechlaner R, Tsimikas S, Yin X, Willeit P, Baig F, Santer P, Oberhollenzer F, Egger G, Witztum JL, Alexander VJ, Willeit J, Kiechl S, Mayr M. Very-Low-Density Lipoprotein-Associated Apolipoproteins Predict Cardiovascular Events and Are Lowered by Inhibition of APOC-III. J Am Coll Cardiol. 2017 Feb 21;69(7):789-800. doi: 10.1016/j.jacc.2016.11.065.

Reference Type BACKGROUND
PMID: 28209220 (View on PubMed)

Kiechl S, Pechlaner R, Willeit P, Notdurfter M, Paulweber B, Willeit K, Werner P, Ruckenstuhl C, Iglseder B, Weger S, Mairhofer B, Gartner M, Kedenko L, Chmelikova M, Stekovic S, Stuppner H, Oberhollenzer F, Kroemer G, Mayr M, Eisenberg T, Tilg H, Madeo F, Willeit J. Higher spermidine intake is linked to lower mortality: a prospective population-based study. Am J Clin Nutr. 2018 Aug 1;108(2):371-380. doi: 10.1093/ajcn/nqy102.

Reference Type DERIVED
PMID: 29955838 (View on PubMed)

Other Identifiers

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Bruneck_2017_Spermidine

Identifier Type: -

Identifier Source: org_study_id