Metabolic Responses to Spermidine Supplementation.

NCT05459961 | Active Not Recruiting

• 1 other identifier: BIO2203
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Evaluation of the safety and effects of a high purity Spermidine supplement in healthy older men.

  Subjects will be evaluated using clinical and laboratory safety testing at baseline and each subsequent study visit. Each participant will be tracked longitudinally during the study using clinical and laboratory safety parameters

  Baseline, and after one, three, four and seven weeks at each study visit. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.

Secondary Outcomes (6)

• Polyamine levels in urine and blood

  Baseline, one week, and one month

• Serum lipidomics

  baseline, one week, and one month

• CRP marker of inflammatory activity

  Baseline, and one month

• Evaluation of molecular biology and bioeffect signalling using untargeted and targeted Metabolomics

  Baseline, one week, and one month. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.

• Urinary untargeted and targeted metabolomics. Evaluation of molecular biology and bioeffect signalling and biomarker assessment

  Baseline, one week, and one month. Change will be evaluated between: (i) baseline, (ii) post-1 week, (iii) post washout crossover baseline, (iv) post 1 week, and (v) post 4 weeks.

Study Arms (2)

active

ACTIVE COMPARATOR

oral spermidine supplement

Dietary Supplement: oral spermidine

placebo

NO INTERVENTION

matching placebo

Interventions

oral spermidine DIETARY_SUPPLEMENT

oral supplement

active

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian men, 50-70 years of age
• 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
• Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial.
• No health conditions that would prevent the subject from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history, physical examination, and routine laboratory test results.
• 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.

You may not qualify if:

• 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.
• Uncontrolled pulmonary (including uncontrolled asthma), cardiac, hepatic, renal, endocrine, hematologic, immunologic, or neurologic disease.
• Had a positive SARS-CoV2 (COVID) test and experienced symptoms for \> 2 months (i.e. long COVID)
• Has a condition the Clinical Investigator believes would interfere with ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk

Sponsors & Collaborators

• Chrysea Labs Lda: lead

Study Sites (1)

Biofortis Innovation Services

Addison, Illinois, 60101, United States

Location

Related Publications (1)

• Keohane P, Everett JR, Pereira R, Cook CM, Blonquist TM, Mah E. Supplementation of spermidine at 40 mg/day has minimal effects on circulating polyamines: An exploratory double-blind randomized controlled trial in older men. Nutr Res. 2024 Dec;132:1-14. doi: 10.1016/j.nutres.2024.09.012. Epub 2024 Sep 19.

  PMID: 39405978 DERIVED

MeSH Terms

Interventions

Spermidine

Intervention Hierarchy (Ancestors)

Putrescine; Biogenic Polyamines; Biogenic Amines; Amines; Organic Chemicals; Polyamines

Study Officials

• Kathleen Kelley, MD

  Biofortis Innovation Services Addison, IL, United States, 60101

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomised double blind placebo controlled

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 15, 2022
• Study Start: August 14, 2022
• Primary Completion: December 25, 2023
• Study Completion: February 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)