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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a pure spermidine supplement might affect aging by examining its roles in cellular processes like antioxidation and immune regulation. Spermidine, naturally found in many plant-based foods, tends to decrease with age. The trial aims to determine if supplementation can positively impact age-related health. Participants will take either the spermidine supplement or a placebo (a pill with no active ingredient) to help identify any beneficial biological markers. Caucasian men aged 50-70 who do not use nicotine or marijuana and can maintain a consistent lifestyle during the study might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on aging and health.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the Clinical Investigator to understand any specific requirements.

Is there any evidence suggesting that spermidine supplementation is likely to be safe for humans?

Research has shown that spermidine is generally safe for people. Studies have found that those taking spermidine usually don't experience common side effects. In fact, many studies reported no negative effects at all. One study mentioned two serious immune system issues, but these were very rare. Another study confirmed that even at high doses, spermidine did not cause harm. Overall, spermidine appears well-tolerated when taken at the recommended doses, typically between 5-10 mg. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spermidine supplementation because it offers a novel approach to promoting health at the cellular level. Unlike standard dietary supplements that might focus on providing vitamins or minerals, spermidine is a polyamine that supports cellular renewal and autophagy, which is the body's process of cleaning out damaged cells. This could potentially lead to improved cell function and longevity. Moreover, spermidine is naturally found in foods like wheat germ, soybeans, and aged cheese, making it a familiar and accessible option for those looking to enhance their health through diet.

What evidence suggests that spermidine supplementation could be effective for age-related biology?

Research suggests that spermidine may benefit brain and mental health, based on animal studies and some early human research. Although these initial human studies have not confirmed improvements in age-related memory problems, they indicate that spermidine could support healthy aging. Spermidine is safe to take; one study found that a 40 mg daily dose for 28 days was well-tolerated by healthy men. This compound also supports crucial cell functions, such as protecting cells from damage and clearing out waste. While more research is needed, these findings suggest spermidine might help maintain health as people age. ^{6 7 8 9 10}

Who Is on the Research Team?

Kathleen Kelley, MD

Principal Investigator

Biofortis Innovation Services Addison, IL, United States, 60101

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10143675/

High-Dose Spermidine Supplementation Does Not Increase ... However, clinical data failed to confirm any positive effects of spermidine on age-related cognitive decline in contrast to preclinical studies, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S027153172400126X

Supplementation of spermidine at 40 mg/day has minimal ... 40 mg/day of high purity spermidine supplement for 28 days is safe in healthy men. Wide safety margin in preclinical toxicology studies supports dosing at 40 ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2792725

Effects of Spermidine Supplementation on Cognition and ... Spermidine supplementation has shown beneficial effects on brain and cognitive health in animal models, and there has been preliminary evidence ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05459961?term=SPERMIDINE&rank=4

Metabolic Responses to Spermidine Supplementation. This study examines the safety and biological effects of pure spermidine on metabolomics, inflammatory and metabolic markers, and transcriptomics in healthy ...

5. aging-us.com aging-us.com/article/101354/text

Safety and tolerability of spermidine supplementation in ... The data demonstrate that spermidine supplementation using a spermidine-rich plant extract is safe and well-tolerated in mice and older adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5807086/

Safety and tolerability of spermidine supplementation in ... Two participants (7.1%) reported a serious adverse event (SAE) during the intervention phase, classified by system organ classes of immune system disorders.

7. lifespan.io lifespan.io/topic/spermidine-benefits-side-effects/

Spermidine: Benefits, Uses, and Side Effects | There are no known adverse side effects from spermidine supplementation. There have been several studies conducted with it, and the results ...

8. fda.gov fda.gov/safety/recalls-market-withdrawals-safety-alerts/supplement-manufacturing-partner-inc-issues-recall-dorado-nutrition-brand-spermidine-supplement-10mg

Supplement Manufacturing Partner, Inc. Issues Recall on ... Supplement Manufacturing Partners, Inc. is recalling Dorado Nutrition brand Spermidine Maximum Strength 10 MG per serving, because it contains undeclared wheat.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0278691523008311

A toxicological assessment of spermidine trihydrochloride ... Spermidine-3HCl was non-genotoxic and showed no adverse effects up to 728 mg/kg bw/day in repeated dose toxicity studies.

10. purovitalis.com purovitalis.com/spermidine-side-effects-myths-vs-reality/

Spermidine Side Effects - Myths vs Reality Spermidine is safe at recommended doses (5-10mg) with no known side effects, and does not cause health problems.