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

Tracking Information

• First Submitted Date: December 14, 2017
• First Posted Date: December 20, 2017
• Last Update Posted Date: December 20, 2017
• Actual Study Start Date: October 1995
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 14, 2017)

All-cause mortality [ Time Frame: 1995-2015 ]

Death due to any cause

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: December 14, 2017)

Cause-specific mortalities [ Time Frame: 1995-2015 ]

Death due to cardiovascular disease, cancer, or other causes

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Spermidine Intake and All-cause Mortality
• Official Title: Association Between Dietary Spermidine Intake and Mortality in the Population-based Bruneck Study
• 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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: A random sample intended to represent the general population, recruited in 1990.

Condition

• Healthy Diet
• Mortality

Intervention

Other: Spermidine content of natural diet

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

• Study Groups/Cohorts: Not Provided

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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 14, 2017): 829
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2015
• Actual Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: None.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 45 Years to 84 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03378843
• Other Study ID Numbers: Bruneck_2017_Spermidine
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

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

• Responsible Party: Stefan Kiechl, Medical University Innsbruck
• Study 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

Investigators

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

• PRS Account: Medical University Innsbruck
• Verification Date: December 2017