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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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

Courtney Millar

Investigators

  • 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)

January 15, 2025

Primary Completion (Actual)

August 13, 2025

Study Completion (Actual)

August 13, 2025

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Insomnia

Clinical Trials on Tart Cherry Juice

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe