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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

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

Condition or disease Intervention/treatment
Healthy Diet Mortality Other: Spermidine content of natural diet

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.

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Study Type : Observational
Actual Enrollment : 829 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association Between Dietary Spermidine Intake and Mortality in the Population-based Bruneck Study
Actual Study Start Date : October 1995
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

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


Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 1995-2015 ]
    Death due to any cause


Secondary Outcome Measures :
  1. Cause-specific mortalities [ Time Frame: 1995-2015 ]
    Death due to cardiovascular disease, cancer, or other causes



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A random sample intended to represent the general population, recruited in 1990.
Criteria

Inclusion Criteria:

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

Exclusion Criteria: None.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03378843


Sponsors and Collaborators
Medical University Innsbruck
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
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Principal Investigator: Stefan Kiechl, MD Medical University of Innsbruck
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stefan Kiechl, A.Univ.-Prof. Dr., Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT03378843    
Other Study ID Numbers: Bruneck_2017_Spermidine
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Kiechl, Medical University Innsbruck:
Polyamine, cardiovascular disease, cancer