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Trial record 1 of 1 for:    NCT03378843
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Spermidine Intake and All-cause Mortality

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ClinicalTrials.gov Identifier: NCT03378843
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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