Sleep ProblemsCherryZZZNCT06786494
Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms
A study testing Tart Cherry Juice in people with Sleep Problems and Insomnia, run by Courtney Millar at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems, Insomnia
- What is being tested?
- Tart Cherry Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2025to 13 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
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.
Read the 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.
- Conditions
- Sleep Problems, Insomnia
- Being tested
- Tart Cherry Juice, Placebo juice
- Keywords
- Montmorency, cherry, flavonoids, sleep quality
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tart Cherry JuiceOther
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 juiceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tart Cherry Juice | Experimental | Not described Receives: Other: Tart Cherry Juice |
| Placebo Juice | Placebo comparator | Not described Receives: Other: Placebo juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of individuals that need to be screened to be enrolled that are randomized to the intervention.
Measured: From first contact until randomization
Attrition
Number of individuals randomized that withdraw from the intervention after randomization and starting the intervention product.
Measured: From randomization until end of 12 week study
Compliance
The number of doses consumed/ the number of intended doses (%)
Measured: From randomization until end of 12 week study
Ability to Collect Data
The percentage of missing data points from electronic capture data devices.
Measured: From enrollment to end of 12 week study
Practicality
Self-reported willingness to continue the dietary regimen after study completion.
Measured: Week 12 study visit
Secondary outcomes (7)
Sleep Quantity (minutes)
Measured: From enrollment to end of 12 week study
Sleep Quality
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.
Measured: Week 1, Week 5, Week 8, Week 12
Urinary melatonin metabolite (6-sulphatoxymelatonin)
Measured: Week 1, Week 5, Week 8, Week 12
Serum Marker of Serotonin (kynurenine/tryptophan ratio in blood)
Measured: Week 1, Week 5, Week 8, Week 12
Urinary Cortisol
Measured: Week 1, Week 5, Week 8, Week 12
Interleukin 6 in blood
Measured: Week 1, Week 5, Week 8, Week 12
C-reactive Protein in Blood
Measured: Week 1, Week 5, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start15 Jan 2025
- Primary completion13 Aug 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Courtney Millar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Courtney Millar, Hebrew SeniorLife
- Investigators
- Courtney Millar, PhD, Principal investigator, Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786494
- Sponsor's protocol ID
- CherryZZZ
- Acronym
- CherryZZZ
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tart Cherry Juice for Sleep in Older Adults With Insomnia: A Pilot Study of Feasibility and Comprehensive Mechanisms
- ClinicalTrials.gov ID
- NCT06786494
- Acronym / sponsor ID
- CherryZZZ / CherryZZZ
- Conditions
- Sleep Problems, Insomnia
- Keywords
- Montmorency, cherry, flavonoids, sleep quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Courtney MillarUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 13 Aug 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tart Cherry Juice | Experimental | Other: Tart Cherry Juice |
| Placebo Juice | Placebo comparator | Other: Placebo juice |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tart Cherry JuiceIndividuals 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. | Other | Tart Cherry Juice |
| Placebo juiceIndividuals 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. | Other | Placebo Juice |
Primary outcome
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.
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.
Compliance
Time frame: From randomization until end of 12 week study
The number of doses consumed/ the number of intended doses (%)
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.
Practicality
Time frame: Week 12 study visit
Self-reported willingness to continue the dietary regimen after study completion.
7 secondary outcomes
Sleep Quantity (minutes)
Time frame: From enrollment to end of 12 week study
Sleep Quality
Time frame: Week 1, Week 5, Week 8, Week 12
Urinary melatonin metabolite (6-sulphatoxymelatonin)
Time frame: 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
Urinary Cortisol
Time frame: Week 1, Week 5, Week 8, Week 12
Interleukin 6 in blood
Time frame: Week 1, Week 5, Week 8, Week 12
C-reactive Protein in Blood
Time frame: Week 1, Week 5, Week 8, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Courtney Millar, PhD principal investigator
Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tart Cherry Juice in people with Sleep Problems and Insomnia, run by Courtney Millar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: From first contact until randomization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.