Tier 2 — strong

Safety and tolerability of spermidine supplementation in mice and older adults with subjective cognitive decline

Claudia Schwarz, Slaven Stekovic, Miranka Wirth, Gloria Benson, Philipp Royer, Stephan J Sigrist, Thomas Pieber, Christopher Dammbrueck, Christoph Magnes, Tobias Eisenberg, Tobias Pendl, Jens Bohlken, Theresa Köbe, Frank Madeo, Agnes Flöel

Aging (Albany NY) 2018 10(1):19-33

Bibliography

PubMed: PMID 29315079
PubMed Central: PMC5807086
DOI: 10.18632/aging.101354
Funding: Funded by the German Federal Ministry of Education and Research, the Hans Gerhard Creutzfeldt scholarship, DFG NeuroCure, BioTechMed-Graz, Austrian Science Fund grants, and BMWFW/University of Graz grants as disclosed in the paper.
Competing interests: Several authors disclosed a financial interest in The Longevity Labs (TLL).

Study snapshot

Design	Phase II randomized, placebo-controlled, double-blind safety and tolerability trial plus preclinical tolerance study
Model	Older adults with subjective cognitive decline; BALB/c mice
Sample	30 humans; mouse tolerance cohorts
Intervention	Spermidine-rich wheat germ extract providing 1.2 mg spermidine/day versus placebo
Duration	3 months in humans; 28 days in mice
Endpoints	Vital signs; Body weight; Clinical chemistry; Hematology; Self-reported health; Tolerability and compliance

What the study showed, in plain terms

This translational study tested whether a spermidine-rich wheat germ extract was tolerated in older adults with subjective cognitive decline. At 1.2 mg/day for three months, safety laboratory measures, vital signs, body weight and self-reported health did not differ from placebo, and compliance exceeded 85%.

Key findings

No meaningful safety signal emerged at 1.2 mg/day over three months. The study supports short-term tolerability of this wheat-germ-derived formulation, not efficacy for cognition or long-term high-dose safety.

What this study can and cannot tell us

Small human sample, short duration and use of a spermidine-rich extract rather than purified spermidine. Several authors disclosed financial interests in The Longevity Labs.

Editorial review

Reviewed by the Biohack Blueprint research team

Khaled Mahmoud