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Spermidine Intake and All-cause Mortality

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03378843
Enrollment
829
Registered
2017-12-20
Start date
1995-10-31
Completion date
2015-10-31
Last updated
2017-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Diet, Mortality

Keywords

Polyamine, cardiovascular disease, cancer

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.

Interventions

OTHERSpermidine content of natural diet

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

Sponsors

Krankenhaus Bruneck
CollaboratorOTHER
University of Graz
CollaboratorOTHER
Paracelsus Medical University
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
King's College London
CollaboratorOTHER
Universitaet Innsbruck
CollaboratorOTHER
Medical University Innsbruck
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 84 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

None.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortality1995-2015Death due to any cause

Secondary

MeasureTime frameDescription
Cause-specific mortalities1995-2015Death due to cardiovascular disease, cancer, or other causes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026