Metabolic Responses to Spermidine Supplementation.

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID: NCT05459961
Run by: Chrysea Labs Lda
People needed: 42
Starts: 2022-08-14
Expected to finish: 2025-02-01
Last updated by the study team: 2024-08-30

Who can join

Age: 50 and older, up to 70. Sex: male. Healthy volunteers: accepted.

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

Where it is running

Biofortis Innovation Services — Addison, Illinois, United States

Full record on ClinicalTrials.gov

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