Saffron reduces some inflammation and oxidative stress markers in donepezil-treated mild-to-moderate Alzheimer's Disease patients: A randomized double-blind placebo-control trial

Abstract

BackgroundMounting evidence indicates the possible positive effects of Crocus sativus (saffron) on cognitive function in patients with Alzheimer’s Disease (AD). This study assessed the effects of saffron on cognitive outcomes and circulatory markers in patients with mild-to-moderate AD. MethodsSixty adults with mild-to-moderate AD were found eligible to take part in a 12-week, randomized double-blind placebo-control clinical trial with a parallel-group design. Volunteers were randomized to receive donepezil plus either saffron capsule at 15 mg/twice a day dose or placebo (n = 30 each). The main outcomes of this study were the changes in the mini-mental state examination (MMSE) score, serum inflammatory markers (IL-1β, IL-6, and TNF-α), and serum antioxidant and oxidative stress status markers (glutathione peroxidase (GPx), superoxide dismutase (SOD), malondialdehyde (MDA), and total antioxidant capacity (TAC)). ResultsMMSE score of the patients in the saffron group was not significantly different from the placebo group (p = 0.303). When compared to the placebo treatment, saffron administration significantly decreased IL-1β (p = 0.036) and MDA (p = 0.021) levels and increased TAC (p = 0.032) in the serum sample of mild-to-moderate AD patients. ConclusionThis study showed no additional effects of saffron supplementation on cognitive outcomes in donepezil-treated mild-to-moderate AD patients; however, patients in the saffron group had improved inflammatory, antioxidant, and oxidative stress profiles compared with the placebo group, which may prove the beneficial effects of the additive on circulatory markers in AD patients.