Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms (CherryZZZ)

Courtney Millar

Status

Completed

Conditions

Sleep Problems

Insomnia

Treatments

Other: Placebo juice

Other: Tart Cherry Juice

Study type

Interventional

Funder types

Other

Identifiers

NCT06786494

CherryZZZ

Details and patient eligibility

About

The purpose of this research study is test if a study that asks older adults with sleep problems to consume tart cherry products is feasible and determine if it can change sleep patterns. This study is a total of 12 weeks. Participants will be asked to consume tart cherry juice for 4 weeks and the placebo juice for 4 weeks, while wearing a digital monitor that measures sleep. Blood (about 3 teaspoons) and urine (about 2 tablespoons) samples will be taken before and after consuming both juices to measure certain biological markers related to sleep.

Full description

The overall goal of this study is to determine feasibility of a tart cherry juice intervention in older adults, and generate preliminary data of outcomes and mechanisms related to sleep. We propose a 2-arm randomized, double-blind, cross-over study in 20 older adults with self-reported insomnia. Participants will consume 240 mL of tart cherry juice or placebo (calorically matched to the tart cherry juice beverage, but theoretically devoid of melatonin, tryptophan, magnesium and flavonoids), twice/evening for 4 weeks in a randomly assigned order.

Enrollment

20 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Men and women aged ≥65 years
Self-reporting insomnia (e.g., trouble sleeping approximately 3 nights a week for at least 6 months and/or an Insomnia Severity Index score ≥ 10 points)
Usual bed-time between 8:00 pm and 1:00 am

Exclusion criteria

Unwilling to follow the study protocol
Inability to properly use the wearable device, complete smartphone-based surveys, or follow the intervention protocol
Self-report of medically diagnosed sleep disorders except insomnia (e.g., sleep apnea)
Current and consistent use of sleep aids or hypnotic prescriptions (e.g., trazadone)
Self-report of cognitive impairment, dementia, or other neurological disorder
Are on unstable medications (i.e., change within the last 3 months) for other conditions
Have an allergy to the intervention products
Self-report history of diabetes
Current alcohol (Alcohol Use Disorders Identification Test ≥4 points33,34) or drug use disorder (Drug Abuse Screening Test,35,36 DAST-10>2 points)
Are excessive caffeine drinkers (>5 cups of caffeinated beverages a day)
Any other reason/condition the PI and investigative team believe this intervention would be unsafe