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NCT Number: NCT05459961

Metabolic Responses to Spermidine Supplementation.

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Subjects

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Biofortis Innovation Services

Addison, Illinois, 60101, United States

About this study

This is a placebo controlled, double blind, randomised, within subject controlled study of supplementation with oral spermidine or placebo each for up to four weeks. The primary objective of this exploratory study is to examine the safety and biological effects of this pure full-dose spermidine supplement on metabolomics, inflammatory and metabolic markers, and transcriptomics.

Study subjects are generally healthy males aged 50-70 After screening, subjects will enter a two week run-in (stabilisation) phase and then be randomised to blinded active or placebo for the first one week supplementation period. After a washout period, subjects will receive either blinded placebo or active for a second supplementation period of up to four weeks. The full study will require six visits by each study subject to the study site over a period of nine weeks, for blood and urine samples, and dietary intake assessments.

Subjects are required to maintain a normal consistent dietary intake during the study and abstain from alcohol in the 24 hours before study visits.

Assays include routine haematology and chemistry, CRP (C reactive protein), lipid screen, serum and urine metabolomics and polyamines, lipidomics, transcriptomics, and autophagy assays.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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.

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

Treatment and study plan

oral spermidine

Dietary Supplement

oral supplement

Primary outcomes

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

    Time frame: 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.

    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

Secondary outcomes

  1. Polyamine levels in urine and blood

    Time frame: Baseline, one week, and one month

    Polyamine levels at each study visit

  2. Serum lipidomics

    Time frame: baseline, one week, and one month

    targeted

  3. CRP marker of inflammatory activity

    Time frame: Baseline, and one month

    C reactive protein

  4. Evaluation of molecular biology and bioeffect signalling using untargeted and targeted Metabolomics

    Time frame: 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.

    Targeted analysis of spermidine, other polyamines, and approximately 250 other biomarkers using both mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy detection technology.

    Untargeted analysis of small molecule biomarkers using MS detection.

    The metabolite profiles of each participant will be tracked longitudinally during the study and changes to targeted or untargeted metabolite profiles occurring between visits due to supplementation or washout from treatment will be evaluated.

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

    Time frame: 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.

    Targeted analysis for small molecule biomarkers of human genomic, dietary and microbiome origin including amino acids (human), 2-furoylglycine (dietary), 3-hydroxyhippurate (microbial metabolism) and approximately 50 others using nuclear magnetic resonance (NMR) detection technology. Untargeted analysis of small molecule biomarkers of human genomic, dietary and microbiome origin using mass spectrometry (MS) and NMR spectroscopy detection.

  6. Autophagy assay

    Time frame: Baseline and one week

    Western blot or Elisa assay

Sponsors and collaborators

Lead sponsor

Chrysea Labs Lda

Industry

Registry information

Official study title

Randomized, Double-Blind, Crossover Study to Assess the Effects of a Spermidine Supplement on Metabolomics in Older Men

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jul 15, 2022
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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