Healthy Subjects
Conditions
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).
Interventions
DIETARY_SUPPLEMENTspermidine
spermidine
Sponsors
Chrysea Labs Lda
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
single blind
Intervention model description
single blind cross over study
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males | Pre dosing to dosing plus six hours | Maximum concentration of circulating spermidine (Cmax) |
| Tmax. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males | Pre dosing to dosing plus six hours | Time to peak of circulating spermidine (Tmax) |
| T 1/2. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males. | Pre dosing to dosing plus six hours | Half-life of circulating spermidine (t1/2) |
| AUC. To evaluate the pharmacokinetics of two different doses (20 mg and 40mg) of spermidine in healthy males | Pre dosing to dosing plus six hours | Area Under the Curve (AUC) |
Countries
Ireland
Outcome results
None listed