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Completed

NCT Number: NCT06786494

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

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.

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Key information

Conditions

Sleep Problems Dyssomnias Insomnia Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tart cherry juice

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. Compliance

    Time frame: From randomization until end of 12 week study

    The number of doses consumed/ the number of intended doses (%)

  4. 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.

  5. Practicality

    Time frame: Week 12 study visit

    Self-reported willingness to continue the dietary regimen after study completion.

Secondary outcomes

  1. Sleep Quantity (minutes)

    Time frame: From enrollment to end of 12 week study

  2. 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.

  3. Urinary melatonin metabolite (6-sulphatoxymelatonin)

    Time frame: Week 1, Week 5, Week 8, Week 12

  4. Serum Marker of Serotonin (kynurenine/tryptophan ratio in blood)

    Time frame: Week 1, Week 5, Week 8, Week 12

  5. Urinary Cortisol

    Time frame: Week 1, Week 5, Week 8, Week 12

  6. Interleukin 6 in blood

    Time frame: Week 1, Week 5, Week 8, Week 12

  7. C-reactive Protein in Blood

    Time frame: Week 1, Week 5, Week 8, Week 12

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Courtney Millar

Other

Registry information

Acronym: CherryZZZ

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 22, 2025
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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