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
| Type | Name | Description |
|---|---|---|
| OTHER | Spermidine content of natural diet | The 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.