Spermidine Intake and All-cause Mortality

• ClinicalTrials.gov Identifier: NCT03378843
• Recruitment Status: Completed
• First Posted: December 20, 2017
• Last Update Posted: December 20, 2017
• Sponsor: Medical University Innsbruck
• Collaborators: Krankenhaus Bruneck; University of Graz; Paracelsus Medical University; Institut National de la Santé Et de la Recherche Médicale, France; King's College London; Universitaet Innsbruck
• Information provided by (Responsible Party): Stefan Kiechl, Medical University Innsbruck

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment
Healthy Diet; Mortality	Other: Spermidine content of natural diet

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 829 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Association Between Dietary Spermidine Intake and Mortality in the Population-based Bruneck Study
• Actual Study Start Date: October 1995
• Actual Primary Completion Date: October 2015
• Actual Study Completion Date: October 2015

Groups and Cohorts

Intervention Details:

• Other: Spermidine content of natural diet
  The exposure consists in the long-term average dietary intake of the polyamine spermidine

Outcome Measures

Primary Outcome Measures :

1. All-cause mortality [ Time Frame: 1995-2015 ]
   Death due to any cause

Secondary Outcome Measures :

1. Cause-specific mortalities [ Time Frame: 1995-2015 ]
   Death due to cardiovascular disease, cancer, or other causes

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 84 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

A random sample intended to represent the general population, recruited in 1990.

Criteria

Inclusion Criteria:

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

Exclusion Criteria: None.

Contacts and Locations

Sponsors and Collaborators

Medical University Innsbruck

Krankenhaus Bruneck

University of Graz

Paracelsus Medical University

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

King's College London

Universitaet Innsbruck

Investigators

• Principal Investigator: Stefan Kiechl, MD; Medical University of Innsbruck

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Stefan Kiechl, A.Univ.-Prof. Dr., Medical University Innsbruck
• ClinicalTrials.gov Identifier: NCT03378843
• Other Study ID Numbers: Bruneck_2017_Spermidine
• First Posted: December 20, 2017
• Last Update Posted: December 20, 2017
• Last Verified: December 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: We do not plan to share individual participant data.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stefan Kiechl, Medical University Innsbruck:

Polyamine, cardiovascular disease, cancer