NCT06017219

Bioavailability of Spermidine in Healthy Males

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Chrysea Labs Lda · Industry
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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 is producing spermidine by a patented biological process to consistently produce very high purity spermidine to pharmaceutical and food grade standards. Using a rat ex vivo jejunal absorption model and 14Carbon labelled spermidine, the recovery rate of radioactivity at the portal vein was approximately 61-76% during the initial 10 minutes after the administration of 14C-spermidine. Data on spermidine absorption in humans is very limited. The purpose of this single blind randomised pharmacokinetic study is to demonstrate absorption of 20mg and 40 mg doses of spermidine in fasted normal volunteers, and to describe the absorption kinetics (Tmax, Cmax, T1/2, AUC).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	spermidine	spermidine

Timeline

• Start date: 2023-05-05
• Primary completion: 2023-10-15
• Completion: 2024-12-14
• First posted: 2023-08-30
• Last updated: 2024-08-30

Locations

1 site across 1 country: Ireland