Spermidine Intake and All-cause Mortality | NCT03378843

Studies
Spermidine Intake and All-cause Mortality

NCT03378843

Sponsor

Medical University Innsbruck

Status

Completed

Last Update Posted

Dec 20, 2017Actual

Enrollment

829Actual

Phase

Not provided

Conditions

Healthy Diet
Mortality

Interventions

Spermidine content of natural diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1995Actual

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Dec 14, 2017

First Submission Date that Met QC Criteria

Dec 14, 2017

First Posted Date

Dec 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2017

Last Update Posted Date

Dec 20, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefan Kiechl, A.Univ.-Prof. Dr., Medical University InnsbruckPrincipal Investigator

Lead Sponsor

Medical University InnsbruckOTHER

Collaborators

Name	Class
Krankenhaus Bruneck	OTHER
University of Graz	OTHER
Paracelsus Medical University	OTHER
Institut National de la Santé Et de la Recherche Médicale, France

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

829Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spermidine content of natural diet	Other	The exposure consists in the long-term average dietary intake of the polyamine spermidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	Death due to any cause	1995-2015

Secondary Outcomes

Measure	Description	Time Frame
Cause-specific mortalities	Death due to cardiovascular disease, cancer, or other causes	1995-2015

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Kiechl, MD	Medical University Innsbruck	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12124407	Background	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.
24622385	Background	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.

ID	Term
D002318	Cardiovascular Diseases
D009369	Neoplasms