Clinical trial NCT06786494: Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms
Official title: Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep Problems
Insomnia
Keywords: Montmorency
cherry
flavonoids
sleep quality
Lead sponsor: Hebrew SeniorLife
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: From first contact until randomization
measure: Attrition
timeFrame: From randomization until end of 12 week study
measure: Compliance
timeFrame: From randomization until end of 12 week study
measure: Ability to Collect Data
timeFrame: From enrollment to end of 12 week study
measure: Practicality
timeFrame: Week 12 study visit
Secondary outcomes:
measure: Sleep Quantity (minutes)
timeFrame: From enrollment to end of 12 week study
measure: Sleep Quality
timeFrame: Week 1, Week 5, Week 8, Week 12
measure: Urinary melatonin metabolite (6-sulphatoxymelatonin)
timeFrame: Week 1, Week 5, Week 8, Week 12
measure: Serum Marker of Serotonin (kynurenine/tryptophan ratio in blood)
timeFrame: Week 1, Week 5, Week 8, Week 12
measure: Urinary Cortisol
timeFrame: Week 1, Week 5, Week 8, Week 12
measure: Interleukin 6 in blood
timeFrame: Week 1, Week 5, Week 8, Week 12
measure: C-reactive Protein in Blood
timeFrame: Week 1, Week 5, Week 8, Week 12
Other outcomes:
measure: Mood
timeFrame: Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
measure: Stress
timeFrame: Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
measure: Pain
timeFrame: Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
Locations:
city: Roslindale
country: United States
facility: Hebrew Rehabilitation Center
state: Massachusetts
Study officials:
affiliation: Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School
name: Courtney Millar, PhD
role: PRINCIPAL_INVESTIGATOR
References: