Tart Cherry Juice for Insomnia

(CherryZZZ Trial)

Overseen By Courtney Millar, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Courtney Millar

Must not be taking: Sleep aids

Disqualifiers: Sleep apnea, Dementia, Diabetes, others

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently and consistently using sleep aids or hypnotic prescriptions, or if your medications have changed in the last 3 months.

What data supports the effectiveness of tart cherry juice as a treatment for insomnia?

Research shows that tart cherry juice can modestly improve sleep in older adults with insomnia, reducing the time awake after falling asleep. It contains melatonin, a natural sleep regulator, which may help enhance sleep quality. ^{1 2 3 4 5}

Is tart cherry juice safe for human consumption?

Tart cherry juice has been studied in various trials and is generally considered safe for human consumption. Some studies have shown it can lower blood pressure and cholesterol, but it may also increase glucose and triglyceride levels. No significant adverse effects were reported in the studies reviewed. ^{1 2 3 4 6}

How does tart cherry juice differ from other treatments for insomnia?

Tart cherry juice is unique because it is a natural treatment that may help improve sleep by containing melatonin, a hormone that regulates sleep, and antioxidants. Unlike traditional hypnotic drugs, which can increase the risk of falls in the elderly, tart cherry juice offers a modest improvement in sleep without these side effects. ^{1 2 3 4 6}

What is the purpose of this trial?

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.

Research Team

Courtney Millar, PhD

Principal Investigator

Hebrew SeniorLife, Marcus Institute of Aging, Harvard Medical School

Eligibility Criteria

This study is for older adults who have trouble sleeping, specifically those with insomnia. Participants will be asked to drink tart cherry juice and a placebo, wear a sleep monitor for 12 weeks, and provide blood and urine samples.

Inclusion Criteria

I have trouble sleeping at least 3 nights a week for 6 months or more.

Usual bed-time between 8:00 pm and 1:00 am

I am 65 years old or older.

Exclusion Criteria

I have a sleep disorder diagnosed by a doctor, but it's not insomnia.

Current alcohol use disorder (Alcohol Use Disorders Identification Test ≥4 points) or drug use disorder (Drug Abuse Screening Test, DAST-10 > 2 points)

Any other reason/condition the PI and investigative team believe this intervention would be unsafe

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume tart cherry juice or placebo juice for 4 weeks each, wearing a digital monitor to measure sleep

8 weeks

Weekly visits for sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Final visit at week 12 for comprehensive assessment

Treatment Details

Interventions

• Placebo juice
• Tart Cherry Juice

Trial Overview The trial is testing whether drinking tart cherry juice improves sleep in older adults with insomnia compared to a placebo. It involves monitoring sleep patterns over 12 weeks and analyzing biological markers from blood and urine samples.

Participant Groups

Group I: Tart Cherry Juice Experimental Treatment 1 Intervention

Group II: Placebo Juice Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Courtney Millar

Lead Sponsor

Trials

1

Recruited

20+

Findings from Research

In a study involving 8 older adults with insomnia, Montmorency tart cherry juice significantly increased sleep time by 84 minutes and improved sleep efficiency, as confirmed by polysomnography.

The mechanism behind these improvements may involve cherry juice procyanidin B-2, which inhibited the enzyme IDO, leading to increased tryptophan availability and reduced inflammation, suggesting a potential natural treatment for insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of the Tart Cherry Juice for the Treatment of Insomnia and Investigation of Mechanisms. Losso, JN., Finley, JW., Karki, N., et al.[2022]

A pilot study involving 15 older adults with chronic insomnia found that a proprietary tart cherry juice blend (CherryPharm) led to significant improvements in sleep continuity and reductions in insomnia severity compared to a placebo.

While the tart cherry juice showed modest benefits for sleep, its effects were less pronounced than those of established insomnia treatments like hypnotic medications and cognitive-behavioral therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study. Pigeon, WR., Carr, M., Gorman, C., et al.[2022]

The study found that Night Time Recharge (NTR), a sleep aid containing cherry extract, significantly increased urinary levels of 6-sulphatoxymelatonin (6-SMT), suggesting enhanced melatonin synthesis, but no melatonin was detected in the supplement itself.

While NTR did not significantly improve overall sleep quality, it did reduce sleep latency, indicating that the tryptophan content in the supplement may play a role in helping individuals fall asleep faster.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a sleep/recovery supplement: 'Night Time Recharge' on sleep parameters in young adults. Simper, T., Gilmartin, M., Allwood, D., et al.[2022]

In a study of 44 participants taking Montmorency tart cherry (MTC) supplements for 30 days, there were no significant improvements in sleep quality or blood pressure, despite both sleep time and quality increasing over the period.

However, participants taking MTC capsules experienced a significant reduction in body mass after 14 days compared to baseline, suggesting a potential benefit of MTC on body weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Montmorency tart cherry supplementation does not impact sleep, body composition, cellular health, or blood pressure in healthy adults. Hillman, AR., Trickett, O., Brodsky, C., et al.[2022]

Intake of Jerte Valley cherries positively influenced sleep patterns and increased levels of 6-sulfatoxymelatonin in middle-aged and elderly participants, suggesting a potential benefit for sleep regulation.

The consumption of these cherries also enhanced urinary total antioxidant capacity, indicating their antioxidant properties may help combat oxidative stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Jerte Valley cherry-enriched diets improve nocturnal rest and increase 6-sulfatoxymelatonin and total antioxidant capacity in the urine of middle-aged and elderly humans. Garrido, M., Paredes, SD., Cubero, J., et al.[2013]

In a 12-week randomized-controlled trial with 37 older adults, tart cherry juice significantly reduced systolic blood pressure and low-density lipoprotein (LDL) cholesterol levels, indicating potential cardiovascular benefits.

While tart cherry juice improved certain lipid profiles, it also led to increases in glucose, triglycerides, and body mass index (BMI), suggesting that further research is needed to fully understand its effects on cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. [2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pilot Study of the Tart Cherry Juice for the Treatment of Insomnia and Investigation of Mechanisms. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of a tart cherry juice beverage on the sleep of older adults with insomnia: a pilot study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The effects of a sleep/recovery supplement: 'Night Time Recharge' on sleep parameters in young adults. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Montmorency tart cherry supplementation does not impact sleep, body composition, cellular health, or blood pressure in healthy adults. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Jerte Valley cherry-enriched diets improve nocturnal rest and increase 6-sulfatoxymelatonin and total antioxidant capacity in the urine of middle-aged and elderly humans. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Impact of tart cherry juice on systolic blood pressure and low-density lipoprotein cholesterol in older adults: a randomized controlled trial. [2018]