Status:
ACTIVE_NOT_RECRUITING
Bioavailability of Spermidine in Healthy Males
Lead Sponsor:
Chrysea Labs Lda
Conditions:
Healthy Subjects
Eligibility:
MALE
18-70 years
Phase:
NA
Brief Summary
To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence of any Adverse Events/Serious adverse events.
Detailed Description
Until now, lack of availability of a reproducible high quality, uncontaminated, spermidine for human consumption as a food or supplement has been a significant barrier to its study and use. Chrysea i...
Eligibility Criteria
Inclusion
- Able to give written informed consent.
- Male.
- Age between 18-70 years inclusive.
- BMI between ≥18.5 and ≤28 kg/m2.
- In general good health, as determined by the investigator.
- Agree to abstain from consuming alcohol, grapefruit, or grapefruit juice for 72 hours prior to visit 2 and visit 3.
- Adequate vein access for cannulation and multiple blood draws.
- Able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
- Willing to consume the study product.
Exclusion
- History of anaphylaxis,
- Documented hypersensitivity reaction or a clinically important reaction to any dietary/food supplement or drug,
- Intolerance or sensitivity to study product ingredients
Key Trial Info
Start Date :
May 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06017219
Start Date
May 5 2023
End Date
December 14 2024
Last Update
August 30 2024
Active Locations (1)
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1
Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork
Cork, Ireland