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

NCT ID: NCT06786494

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-08-13

Brief Summary

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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

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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.

Conditions

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Sleep Problems Insomnia

Keywords

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Montmorency cherry flavonoids sleep quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Tart Cherry Juice

Group Type EXPERIMENTAL

Tart Cherry Juice

Intervention Type OTHER

Individuals will be asked to consume 240 mL (i.e., 8 ounces) at approximately 5 pm and 240 mL (i.e., 8 ounces) of tart cherry juice at approximately 1 hour before bedtime for 4 weeks.

Placebo Juice

Group Type PLACEBO_COMPARATOR

Placebo juice

Intervention Type OTHER

Individuals will be asked to consume 240 mL (i.e., 8 ounces) at approximately 5 pm and 240 mL (i.e., 8 ounces) of placebo juice at approximately 1 hour before bedtime for 4 weeks.

Interventions

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Tart Cherry Juice

Individuals will be asked to consume 240 mL (i.e., 8 ounces) at approximately 5 pm and 240 mL (i.e., 8 ounces) of tart cherry juice at approximately 1 hour before bedtime for 4 weeks.

Intervention Type OTHER

Placebo juice

Individuals will be asked to consume 240 mL (i.e., 8 ounces) at approximately 5 pm and 240 mL (i.e., 8 ounces) of placebo juice at approximately 1 hour before bedtime for 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Courtney Millar

OTHER

Sponsor Role lead

Responsible Party

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Courtney Millar

Assistant Scientist II

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Courtney Millar, PhD

Role: PRINCIPAL_INVESTIGATOR

Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School

Locations

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Hebrew Rehabilitation Center

Roslindale, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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CherryZZZ

Identifier Type: -

Identifier Source: org_study_id