Clinical trial NCT03378843: Spermidine Intake and All-cause Mortality
Official title: Association Between Dietary Spermidine Intake and Mortality in the Population-based Bruneck Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Diet
Mortality
Keywords: Polyamine, cardiovascular disease, cancer
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Krankenhaus Bruneck
name: University of Graz
name: Paracelsus Medical University
name: Institut National de la Santé Et de la Recherche Médicale, France
name: King's College London
name: Universitaet Innsbruck
First posted: 2017-12-20
Enrollment: 829
Sex: ALL
Minimum age (years): 45
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A random sample intended to represent the general population, recruited in 1990.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria: None.

Primary outcomes:
measure: All-cause mortality
timeFrame: 1995-2015
Secondary outcomes:
measure: Cause-specific mortalities
timeFrame: 1995-2015
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Innsbruck
name: Stefan Kiechl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.