Bioavailability of Spermidine in Healthy Males

Study Overview
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Brief Summary
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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
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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).

Official Title
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Bioavailability of Spermidine in Healthy Males

Conditions
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Healthy Subjects

Intervention / Treatment
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* Dietary Supplement: spermidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: single blind cross over study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: within subject control 20mg<br>spermidine | Dietary Supplement: spermidine<br>* spermidine<br>|
| Experimental: within subject control 40mg<br>spermidine | Dietary Supplement: spermidine<br>* spermidine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 |