Bioavailability of Spermidine in Healthy Males

Healthy Subjects Clinical Trial

Official title:

Bioavailability of Spermidine in Healthy Males

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06017219
• Other study ID #: AFCRO 167
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: March 14, 2024

Study information

• Verified date: August 2023
• Source: Chrysea Labs Lda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate in healthy males the safety of two doses of spermidine as assessed by occurrence of any Adverse Events/Serious adverse events.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: March 14, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Dietary Supplement:
• spermidine
spermidine

Locations

Country	Name	City	State
Ireland	Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork	Cork

Sponsors (1)

Lead Sponsor	Collaborator
Chrysea Labs Lda

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

Uda K, Tsujikawa T, Fujiyama Y, Bamba T. Rapid absorption of luminal polyamines in a rat small intestine ex vivo model. J Gastroenterol Hepatol. 2003 May;18(5):554-9. doi: 10.1046/j.1440-1746.2003.03020.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males	Maximum concentration of circulating spermidine (Cmax)	Pre dosing to dosing plus six hours
Primary	Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males	Time to peak of circulating spermidine (Tmax)	Pre dosing to dosing plus six hours
Primary	T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males.	Half-life of circulating spermidine (t1/2)	Pre dosing to dosing plus six hours
Primary	AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males	Area Under the Curve (AUC)	Pre dosing to dosing plus six hours