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

NCT06786494 | Completed

• 1 other identifier: CherryZZZ
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sleep Problems; Insomnia

Keywords

Montmorency; cherry; flavonoids; sleep quality

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Number of individuals that need to be screened to be enrolled that are randomized to the intervention.

  From first contact until randomization

• Attrition

  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

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

  From randomization until end of 12 week study

• Ability to Collect Data

  The percentage of missing data points from electronic capture data devices.

  From enrollment to end of 12 week study

• Practicality

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

  Week 12 study visit

Secondary Outcomes (7)

• Sleep Quantity (minutes)

  From enrollment to end of 12 week study

• Sleep Quality

  Week 1, Week 5, Week 8, Week 12

• Urinary melatonin metabolite (6-sulphatoxymelatonin)

  Week 1, Week 5, Week 8, Week 12

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

  Week 1, Week 5, Week 8, Week 12

• Urinary Cortisol

  Week 1, Week 5, Week 8, Week 12

Other Outcomes (3)

• Mood

  Week 1, Week 3, Week 5, Week 8, Week 10, Week 12

• Stress

  Week 1, Week 3, Week 5, Week 8, Week 10, Week 12

• Pain

  Week 1, Week 3, Week 5, Week 8, Week 10, Week 12

Study Arms (2)

Tart Cherry Juice

EXPERIMENTAL

Other: Tart Cherry Juice

Placebo Juice

PLACEBO COMPARATOR

Other: Placebo juice

Interventions

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.

Placebo Juice

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.

Tart Cherry Juice

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Courtney Millar: lead

Study Sites (1)

Hebrew Rehabilitation Center

Roslindale, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Courtney Millar, PhD

  Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Scientist II

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 22, 2025
• Study Start: January 15, 2025
• Primary Completion: August 13, 2025
• Study Completion: August 13, 2025
• Last Updated: March 23, 2026

Record last verified: 2026-02

Locations

US (1)