Keohane, Patrick, Everett, Jeremy, Pereira, Rui, EVERETT, Jeremy, Blonquist, Traci and Mah, Eunice (2024) Supplementation of spermidine at 40 mg/day has minimal effects on circulating polyamines: an exploratory double-blind randomized controlled trial in older men. Nutrition Research. ISSN 0271-5317 (Print), 1879-0739 (Online) (doi:https://doi.org/10.1016/j.nutres.2024.09.012)

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Abstract

This study represents the first investigation into the safety of a novel, high-purity spermidine-trihydrochloride supplement (hpSPD) in humans. Spermidine, a natural compound found in various foods, has demonstrated potential health benefits in animal and epidemiological studies. However, evidence from clinical trials and safety evaluations of spermidine supplements is limited as pure spermidine for human administration has not been available. In this randomized, double-blind, within subject and placebo-controlled trial, 37 healthy men (50-70 years old, BMI 18.5-28 kg/m2) were administered either hpSPD or a placebo. We hypothesized that 7-day and 28-day dosing of 40 mg/day of hsSPD would have minimal effects on safety, although metabolic and polyamine homeostasis has not previously been examined at this dosage level. Consistent with our hypothesis, 40 mg/day hpSPD did not result in any significant changes in clinical, lipids, chemistry, or hematological parameters compared to placebo. Compliance was high, and no study product-related adverse events were reported. Substantial changes in serum and urine polyamine concentrations were not observed following hpSPD supplementation, suggesting effective homeostatic control of full dose highly purified spermidine supplements with no evidence of adaptation of spermidine metabolism at 40 mg/day. These findings suggest that hpSPD at 40 mg/day for up to 28 days is safe and well-tolerated in healthy older men. The study is consistent with preclinical results and provides important evidence supporting the safety of high-purity spermidine supplementation, enabling further research with single molecule spermidine to investigate its potential biology for improving human health. This trial was registered at clinicaltrials.gov (NCT05459961).

Item Type:	Article
Uncontrolled Keywords:	anti-aging; spermidine; autophagy; human dose; cardiovascular; natural; longevity; safety
Subjects:	Q Science > Q Science (General)
Faculty / School / Research Centre / Research Group:	Faculty of Engineering & Science Faculty of Engineering & Science > School of Science (SCI)
Related URLs:	https://www.sciencedirect.com/science/ar...
Last Modified:	27 Sep 2024 13:46
URI:	http://gala.gre.ac.uk/id/eprint/48214

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