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
|Condition or disease||Intervention/treatment|
|Healthy Diet Mortality||Other: Spermidine content of natural diet|
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.
|Study Type :||Observational|
|Actual Enrollment :||829 participants|
|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|
- Other: Spermidine content of natural diet
The exposure consists in the long-term average dietary intake of the polyamine spermidine
- All-cause mortality [ Time Frame: 1995-2015 ]Death due to any cause
- Cause-specific mortalities [ Time Frame: 1995-2015 ]Death due to cardiovascular disease, cancer, or other causes
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
|Principal Investigator:||Stefan Kiechl, MD||Medical University of Innsbruck|