- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01669317
Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content (CHERRY JUICE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will consist of 4 visits - 1 screening visit and 3 treatment visits. Screening visit will consist of a fasting chemistry panel, a health questionnaire, an Insomnia Severity Index, the Epworth Sleepiness Scale, the Pittsburgh Sleep Quality Index, the Beck Depression Inventory, the State-Trait Anxiety Inventory, and the Fatigue Severity Scale.
Ten subjects passing screening will take for 2 weeks between dinner and bedtime in a blinded and balanced order: 1. Eight ounces of cherry juice standardized to its proanthocyanidin content in the morning and 8 ounces of cherry juice standardized to its procyanidin content 1-2 hours before bedtime for 14 days; 2. A similar amount of placebo juice with the same timing for the cross-over. There will be a 2-week washout between each of the treatment periods. Subjects will be scheduled for two overnight PSGs, one at the end of each two-week treatment period. On the morning following each test the insomnia severity index and other questionnaires will be repeated. The order of the placebo juice and cherry juice will be random and balanced.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Louisiana
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Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy male or female with a usual bedtime between 9 pm and midnight.
- 65 years of age or older.
- Sleep problem >3 nights per week, meeting the International Classification of Sleep Disorders (ICSD-2*) diagnostic criteria of insomnia for at least 6 months.
An insomnia severity index ≥ 10 and a minimum of 30 minutes of either sleep-onset latency (SL) or wake after sleep onset (WASO).
*ICSD-2 general criteria for insomnia:
- A complaint of difficulty initiating sleep, difficulty maintaining sleep, or waking up too early, or sleep that is chronically non-restorative or poor in quality.
- The above sleep difficulty occurs despite adequate opportunity and circumstances for sleep.
- At least one of the following forms of daytime impairment related to the nighttime sleep difficulty is reported by the patient:
- Fatigue or malaise.
- Attention, concentration, or memory impairment.
- Social or vocational dysfunction or poor school performance.
- Mood disturbance or irritability.
- Daytime sleepiness.
- Motivation, energy, or initiative reduction.
- Proneness for errors or accidents at work or while driving.
- Tension, headaches, or gastrointestinal symptoms in response to sleep loss.
- Concerns or worries about sleep.
Exclusion Criteria:
- Diabetes.
- Sedating or hypnotic medications.
- Any chronic medication that has not had a stable dose for 1 month or longer.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cherry Juice Standardized
You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory.
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You will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory.
You will be given an 8-ounce glass of artificial cherry juice
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Placebo Comparator: Artificial Cherry Juice
You will be given an 8-ounce glass of artificial cherry juice to drink when you arrive at the Sleep Laboratory.
|
You will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory.
You will be given an 8-ounce glass of artificial cherry juice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the polysomnography of participants with insomnia
Time Frame: Baseline and Week 4
|
Compare the polysomnography of participants with insomnia on a night at the end of 2 weeks taking: Eight ounces of standardized cherry juice vs. the night taking the placebo juice.
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Baseline and Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the Insomnia Severity Index and validated questionnaires
Time Frame: Baseline and Week 4
|
Compare the Insomnia Severity Index, a validated questionnaire, in participants with insomnia on a night at the end of 2 weeks taking: 1.
Eight ounces of cherry juice standardized to its proanthocyanidin content in the morning, and 1-2 hours before bedtime; 2. Eight ounces of an identical appearing placebo in the morning and 1-2 hours before bedtime.
|
Baseline and Week 4
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Comparison of insomnia sleep scales
Time Frame: Baseline and Week 4
|
Compare five different sleep quality scales with insomnia on a night at the end of 2 weeks taking: 1.
An 8-ounce glass of cherry juice standardized to its proanthocyanidin content in the morning and 1-2 hours before bedtime; 2. an 8- ounce glass of an identical appearing placebo in the morning and 1-2 hours before bedtime.
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Baseline and Week 4
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Differences in the enzyme blood test
Time Frame: Baseline, Week 2 & Week 4
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compare the expression of enzyme blood test of participants taking the standardized cherry juice vs. the the placebo juice.
|
Baseline, Week 2 & Week 4
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frank Greenway, MD, Study Principal Investigator
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 12004
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.
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