Clinical Trials Directory

Trials / Completed

CompletedNCT03378843

Spermidine Intake and All-cause Mortality

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

Status
Completed
Phase
Study type
Observational
Enrollment
829 (actual)
Sponsor
Medical University Innsbruck · Academic / Other
Sex
All
Age
45 Years – 84 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSpermidine content of natural dietThe exposure consists in the long-term average dietary intake of the polyamine spermidine

Timeline

Start date
1995-10-01
Primary completion
2015-10-01
Completion
2015-10-01
First posted
2017-12-20
Last updated
2017-12-20

Source: ClinicalTrials.gov record NCT03378843. Inclusion in this directory is not an endorsement.