Healthy SubjectsNCT05459961
Metabolic Responses to Spermidine Supplementation.
A study testing oral spermidine in people with Healthy Subjects, run by Chrysea Labs Lda at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- oral spermidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2022to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Innovation Services
Addison, Illinois, 60101
About this study
Official title: Randomized, Double-Blind, Crossover Study to Assess the Effects of a Spermidine Supplement on Metabolomics in Older Men
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.
Read the detailed description
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.
- Conditions
- Healthy Subjects
- Being tested
- oral spermidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral spermidineDietary supplement
oral supplement
| Study group | Role | What they receive |
|---|---|---|
| active | Active comparator | oral spermidine supplement Receives: Dietary Supplement: oral spermidine |
| placebo | No intervention | matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Polyamine levels at each study visit
Measured: Baseline, one week, and one month
Serum lipidomics
targeted
Measured: baseline, one week, and one month
CRP marker of inflammatory activity
C reactive protein
Measured: Baseline, and one month
Evaluation of molecular biology and bioeffect signalling using untargeted and targeted Metabolomics
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.
Measured: 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
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.
Measured: 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.
Autophagy assay
Western blot or Elisa assay
Measured: Baseline and one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start14 Aug 2022
- Primary completion25 Dec 2023
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomised double blind placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chrysea Labs Lda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Kelley, MD, Principal investigator, Biofortis Innovation Services Addison, IL, United States, 60101
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459961
- Sponsor's protocol ID
- BIO2203
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2022
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39405978
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Crossover Study to Assess the Effects of a Spermidine Supplement on Metabolomics in Older Men
- ClinicalTrials.gov ID
- NCT05459961
- Acronym / sponsor ID
- BIO2203
- Conditions
- Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Chrysea Labs LdaIndustry (pharma, biotech, devices)
- Study start
- 14 Aug 2022 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- Feb 2025 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised double blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| active | Active comparator | Dietary Supplement: oral spermidineoral spermidine supplement |
| placebo | No intervention | –matching placebo |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral spermidineoral supplement | Dietary supplement | active |
Primary outcome
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
6 secondary outcomes
Polyamine levels in urine and blood
Time frame: Baseline, one week, and one month
Serum lipidomics
Time frame: baseline, one week, and one month
CRP marker of inflammatory activity
Time frame: Baseline, and one month
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.
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.
Autophagy assay
Time frame: Baseline and one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Derived from this study: PubMed 39405978Keohane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Kelley, MD principal investigator
Biofortis Innovation Services Addison, IL, United States, 60101
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral spermidine in people with Healthy Subjects, run by Chrysea Labs Lda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05459961, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.