CherryZZZ: A Protocol for a Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study Testing Tart Cherry Juice in Older Adults with Self-Reported Insomnia

<b>Introduction:</b> Two small, preliminary pilot studies report that 2 weeks of daily tart cherry juice consumption (half of the dose in the morning, half of the dose at night) may increase sleep quantity (assessed via a sleep diary or 1 night of polysomnography) in older adults with insomnia. A study of longer duration, with doses closer to bedtime, and daily objective monitoring of sleep via a wearable device may potentiate the observed impact of tart cherry juice intake on sleep. With the proposed changes to the study protocol, it is paramount to evaluate the study's feasibility. <b>Methods:</b> The current study is a single-site, randomized, double-blind, cross-over pilot study in 20 older adults with self-reported insomnia. Eligible individuals will be randomly assigned to consume 16 oz. of tart cherry juice/day or placebo juice for 4 weeks each, separated by a 3-week washout period. Information on study feasibility, including recruitment rate, retention rate, safety, compliance, and study practicality, will be collected, as well as pre- and post-arm evaluations of sleep quantity/quality and biomarkers related to melatonin, cortisol, serotonin, and inflammation. <b>Discussion:</b> Identification of a dietary intervention that improves sleep quantity and quality may serve as a novel and feasible approach for older adults who suffer from insomnia. If successful, such a strategy would help mitigate the plethora of health consequences associated with poor sleep.