Bioavailability of Spermidine in Healthy Males

NCT ID: NCT06017219

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2024-12-14

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

within subject control 20mg

spermidine

Group Type: EXPERIMENTAL

spermidine

Intervention Type: DIETARY_SUPPLEMENT

spermidine

within subject control 40mg

spermidine

Group Type: EXPERIMENTAL

spermidine

Intervention Type: DIETARY_SUPPLEMENT

spermidine

Interventions

spermidine

spermidine

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chrysea Labs Lda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Patrick Keohane

Role: STUDY_DIRECTOR

Chrysea Labs

Locations

Atlantia Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park, Cork

Cork, , Ireland

Countries

Ireland

References

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.

Reference Type: BACKGROUND

PMID: 12702048 (View on PubMed)

Other Identifiers

AFCRO 167

Identifier Type: -

Identifier Source: org_study_id