Bioavailability of Spermidine in Healthy Males

Chrysea Labs

Status

Active, not recruiting

Conditions

Healthy Subjects

Treatments

Dietary Supplement: spermidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT06017219

AFCRO 167

Details and patient eligibility

About

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

Full 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).

Enrollment

6 estimated patients

Sex

Male

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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