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Completed

NCT Number: NCT03378843

Spermidine Intake and All-cause Mortality

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

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Key information

Conditions

Healthy Diet Cardiovascular Diseases Mortality Neoplasms

Age range

45 year–84 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None.

Treatment and study plan

Spermidine content of natural diet

Other

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

Primary outcomes

  1. All-cause mortality

    Time frame: 1995-2015

    Death due to any cause

Secondary outcomes

  1. Cause-specific mortalities

    Time frame: 1995-2015

    Death due to cardiovascular disease, cancer, or other causes

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
1995
Primary completion
2015
Study completion
2015
First posted
Dec 20, 2017
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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