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
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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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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

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Ages Eligible for Study: | 45 Years to 84 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Resident of Bruneck aged 40-79 years in 1990, age- and sex-stratified random sample.
Exclusion Criteria: None.

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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stefan Kiechl, A.Univ.-Prof. Dr., Medical University Innsbruck |
ClinicalTrials.gov Identifier: | NCT03378843 |
Other Study ID Numbers: |
Bruneck_2017_Spermidine |
First Posted: | December 20, 2017 Key Record Dates |
Last Update Posted: | December 20, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | We do not plan to share individual participant data. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Polyamine, cardiovascular disease, cancer |