Spermidine Intake and All-cause Mortality

Mortality Clinical Trial

Official title:

Association Between Dietary Spermidine Intake and Mortality in the Population-based Bruneck Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03378843
• Other study ID #: Bruneck_2017_Spermidine
• Status: Completed
• Phase: N/A
• First received: December 14, 2017
• Last updated: December 14, 2017
• Start date: October 1995
• Est. completion date: October 2015

Study information

• Verified date: December 2017
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 829
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 84 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria: None.

Related Conditions & MeSH terms

• Healthy Diet
• Mortality

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Medical University Innsbruck	Institut National de la Santé Et de la Recherche Médicale, France, King's College London, Krankenhaus Bruneck, Paracelsus Medical University, Universitaet Innsbruck, University of Graz

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	Death due to any cause	1995-2015
Secondary	Cause-specific mortalities	Death due to cardiovascular disease, cancer, or other causes	1995-2015