Ketogenic dietary lifestyle intervention effects on sleep, cognition, and behavior in mild cognitive impairment: Study design.

Introduction: Sleep and diet are modifiable risk factors for Alzheimer's disease (AD) that may be salient areas for the development of preventive intervention strategies against dementia in people with mild cognitive impairment (MCI). Sleep disturbances account for up to 15% of the population attributable risk for AD. Diet influences sleep quality, such that diets high in sugars, fat, and processed food affect sleep quality and cognition in older adults. The combination of poor sleep and diet health may increase risk for dementia in people with MCI, yet it is unknown how intervening on diet may influence sleep health. Methods: The MCI Sleep Study assesses longitudinal changes in objective and subjective measures of sleep between two investigational diet groups in the Brain Energy for Amyloid Transformation in Alzheimer's Disease study: the modified Mediterranean ketogenic diet (MMKD) and the American Heart Association diet. Objective sleep assessments include an in-home sleep study using the WatchPAT Central Plus (Itamar Medical, Ltd) at baseline and the end of the 4-month diet intervention. Subjective sleep questionnaires include the Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index. The MCI Sleep Study outcome measures include longitudinal change in cognitive performance, mood, behavior, and quality of life. Results: Study recruitment is currently ongoing. We hypothesize the low-carb MMKD diet to have a beneficial impact on sleep health in individuals with MCI. Pre- and post-diet changes in sleep metrics across diet groups will be examined using mixed effects analysis of variance models. Discussion: Early assessment of chronic sleep and diet behaviors may be vital in understanding when interventions are necessary and the lifestyle modifications that should accompany future AD prevention and therapy recommendations.