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

March 18, 2026 updated by: Courtney Millar
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Roslindale, Massachusetts, United States, 02131
        • Hebrew Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tart Cherry Juice
Other: 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.
Placebo Comparator: Placebo Juice
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: From first contact until randomization
Number of individuals that need to be screened to be enrolled that are randomized to the intervention.
From first contact until randomization
Attrition
Time Frame: From randomization until end of 12 week study
Number of individuals randomized that withdraw from the intervention after randomization and starting the intervention product.
From randomization until end of 12 week study
Compliance
Time Frame: From randomization until end of 12 week study
The number of doses consumed/ the number of intended doses (%)
From randomization until end of 12 week study
Ability to Collect Data
Time Frame: From enrollment to end of 12 week study
The percentage of missing data points from electronic capture data devices.
From enrollment to end of 12 week study
Practicality
Time Frame: Week 12 study visit
Self-reported willingness to continue the dietary regimen after study completion.
Week 12 study visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Quantity (minutes)
Time Frame: From enrollment to end of 12 week study
From enrollment to end of 12 week study
Sleep Quality
Time Frame: Week 1, Week 5, Week 8, Week 12
The validated self-report questionnaire, the Pittsburg Sleep Quality Index, will be used as a measure of sleep quality. This instrument ranges from 0-21 points, with higher scores indicating worse sleep quality.
Week 1, Week 5, Week 8, Week 12
Urinary melatonin metabolite (6-sulphatoxymelatonin)
Time Frame: Week 1, Week 5, Week 8, Week 12
Week 1, Week 5, Week 8, Week 12
Serum Marker of Serotonin (kynurenine/tryptophan ratio in blood)
Time Frame: Week 1, Week 5, Week 8, Week 12
Week 1, Week 5, Week 8, Week 12
Urinary Cortisol
Time Frame: Week 1, Week 5, Week 8, Week 12
Week 1, Week 5, Week 8, Week 12
Interleukin 6 in blood
Time Frame: Week 1, Week 5, Week 8, Week 12
Week 1, Week 5, Week 8, Week 12
C-reactive Protein in Blood
Time Frame: Week 1, Week 5, Week 8, Week 12
Week 1, Week 5, Week 8, Week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mood
Time Frame: Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
A validated self-report questionnaire, the Center for Epidemiological Studies Depression Scale, will be used to evaluate mood/depressive symptom severity. This instrument ranges from 0-60 points, with higher scores indicating more severe symptoms of depression.
Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
Stress
Time Frame: Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
The validated self-report questionnaire, the Perceived Stress Scale, will be used to evaluate stress. This instrument ranges from 0-56 points, with higher scores indicating more stress.
Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
Pain
Time Frame: Week 1, Week 3, Week 5, Week 8, Week 10, Week 12
The validated self-report questionnaire, the Geriatric Pain Measure, will be used to evaluate pain. This instrument ranges from 0-42 points, with higher scores indicating more severity of pain.
Week 1, Week 3, Week 5, Week 8, Week 10, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Courtney Millar

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Courtney Millar, PhD, Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CherryZZZ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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