Journal
AGING-US
Volume 10, Issue 1, Pages 19-33Publisher
IMPACT JOURNALS LLC
DOI: 10.18632/aging.101354
Keywords
polyamines; dietary supplement; spermidine; safety; subjective cognitive decline; aging
Categories
Funding
- Bundesministerium fur Bildung und Forschung [FKZ 01GQ1420B]
- Hans Gerhard Creutzfeldt scholarship (FKZ CSB II) [01EO1301 TP T2]
- Deutsche Forschungsgemeinschaft (DFG) [EXC 257 NeuroCure]
- Austrian Science Fund FWF (Austria) [P29262, P29203, P27893]
- SFB Lipotox [F3012]
- BMWFW
- Karl-Franzens University [80.109/0001 -WF/V/3b/2015]
- BioTechMed-Graz
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Supplementation of spermidine, an autophagy-inducing agent, has been shown to protect against neurodegeneration and cognitive decline in aged animal models. The present translational study aimed to determine safety and tolerability of a wheat germ extract containing enhanced spermidine concentrations. In a preclinical toxicity study, supplementation of spermidine using this extract did not result in morbidities or changes in behavior in BALBc/Rj mice during the 28-days repeated-dose tolerance study. Post mortem examination of the mice organs showed no increase in tumorigenic and fibrotic events. In the human cohort (participants with subjective cognitive decline, n = 30, 60 to 80 years of age), a 3-month randomized, placebo-controlled, double-blind Phase II trial was conducted with supplementation of the spermidine-rich plant extract (dosage: 1.2 mg/day). No differences were observed between spermidine and placebo-treated groups in vital signs, weight, clinical chemistry and hematological parameters of safety, as well as in self-reported health status at the end of intervention. Compliance rates above 85% indicated excellent tolerability. The data demonstrate that spermidine supplementation using a spermidine-rich plant extract is safe and well-tolerated in mice and older adults. These findings allow for longer-term intervention studies in humans to investigate the impact of spermidine treatment on cognition and brain integrity.
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