Spermidine Supplementation for Healthy Subjects

Overseen By Dr Patrick Keohane

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Chrysea Labs Lda

Disqualifiers: Diabetes, Uncontrolled asthma, Long COVID, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

42 Participants Needed

Trial Summary

What is the purpose of this trial?

Spermidine is naturally present in cells, organs, circulating cardiovascular system, and as part of our normal dietary intake. Studies suggest Spermidine is involved in antioxidation, autophagy, apoptosis, and immune regulation. Spermidine is typically present in foods of plant origin, such as natto, beans, fruits, vegetables, cheese, potatoes, bread, and cereals. Adequate spermidine dietary intake is important, given evidence of declining spermidine levels with age in humans and other species, and the evidence for positive effects of spermidine supplementation on age related biology. To date, human research studies utilised extracts containing low levels of spermidine (\< 10%) and multiple other constituents, but this study will use pure spermidine to explore relevant mechanisms of action, biological effects, and identify potential biomarkers of positive biological effects.

Research Team

Kathleen Kelley, MD

Principal Investigator

Biofortis Innovation Services Addison, IL, United States, 60101

Eligibility Criteria

This trial is for healthy Caucasian men aged 50-70 who don't use nicotine or marijuana products and haven't for at least 6 months. Participants should maintain their usual diet, weight, and exercise routine, have no significant health issues as determined by a doctor, including uncontrolled diseases or long COVID symptoms.

Inclusion Criteria

Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator

Non-user or former users (cessation ≥6 months) of nicotine products (e.g., cigarettes, chewing tobacco) during the study period

Non-user or former users (cessation ≥6 months) of any marijuana or hemp products and no plans to use marijuana or hemp products during the study period

Exclusion Criteria

Abnormal laboratory test results of clinical significance

Clinically important gastrointestinal (GI) condition that would potentially interfere with the evaluation of the study product

Type I or Type II diabetes mellitus

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Run-in (Stabilisation)

Participants undergo a two-week run-in phase to stabilize conditions before randomization

2 weeks

1 visit (in-person)

Treatment Period 1

Participants receive either oral spermidine or placebo for one week

1 week

1 visit (in-person)

Washout

Participants undergo a washout period before the second treatment period

1 week

Treatment Period 2

Participants receive either oral spermidine or placebo for up to four weeks

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Spermidine

Trial Overview The study tests the effects of pure spermidine taken orally on healthy individuals. Spermidine is linked to various cellular processes like antioxidation and immune regulation and is found in many plant-based foods. The trial aims to understand its biological impact better.

Participant Groups

Group I: active Active Control 1 Intervention

oral spermidine supplement

Group II: placebo Active Control 1 Intervention

matching placebo

Who Is Running the Clinical Trial?

Chrysea Labs Lda

Lead Sponsor

Trials

2

Recruited

50+