NCT03378843

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
829

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 1995

Longer than P75 for all trials

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

October 1, 1995

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 20, 2017

Completed
Last Updated

December 20, 2017

Status Verified

December 1, 2017

Enrollment Period

20 years

First QC Date

December 14, 2017

Last Update Submit

December 14, 2017

Conditions

Keywords

Polyamine, cardiovascular disease, cancer

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    Death due to any cause

    1995-2015

Secondary Outcomes (1)

  • Cause-specific mortalities

    1995-2015

Interventions

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

Eligibility Criteria

Age45 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 12124407BACKGROUND
  • 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.

    PMID: 24622385BACKGROUND
  • 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.

    PMID: 28209220BACKGROUND
  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesNeoplasms

Study Officials

  • Stefan Kiechl, MD

    Medical University of Innsbruck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A.Univ.-Prof. Dr.

Study Record Dates

First Submitted

December 14, 2017

First Posted

December 20, 2017

Study Start

October 1, 1995

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 20, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

We do not plan to share individual participant data.