- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05459961
Metabolic Responses to Spermidine Supplementation.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr Patrick Keohane
- Phone Number: +442086385169
- Email: pk@chrysealabs.com
Study Contact Backup
- Name: Ruth DaCunha
- Phone Number: +351 231410890
- Email: rdc@chrysealabs.com
Study Locations
-
-
Illinois
-
Addison, Illinois, United States, 60101
- Biofortis Innovation Services
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: active
oral spermidine supplement
|
oral supplement
|
No Intervention: placebo
matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, including lipids, lipoproteins, cholesterol and cholesterol esters, triglycerides, phospholipids, fatty acids and apolipoproteins using both mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy detection technology. Untargeted analysis of small molecule biomarkers of both human genomic and microbiome origin 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. |
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum lipidomics
Time Frame: baseline, one week, and one month
|
targeted
|
baseline, one week, and one month
|
CRP marker of inflammatory activity
Time Frame: baseline, and one month
|
C reactive protein
|
baseline, and one month
|
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.
|
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.
|
Polyamine levels in urine and blood
Time Frame: baseline, one week, and one month
|
Polyamine levels at each study visit
|
baseline, one week, and one month
|
Autophagy assay
Time Frame: baseline and one week
|
Western blot and Elisa assay
|
baseline and one week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathleen Kelley, MD, Biofortis Innovation Services Addison, IL, United States, 60101
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BIO2203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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