InsomniaCHERRY JUICENCT01669317
Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content
A study testing 8-ounce glass of cherry juice and Artificial Cherry Juice in people with Insomnia and Sleep Problem, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
This study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Sleep Problem
- What is being tested?
- 8-ounce glass of cherry juice and Artificial Cherry Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2015
- 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
- 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.
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- 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.
Who cannot join
- Diabetes.
- Sedating or hypnotic medications.
- Any chronic medication that has not had a stable dose for 1 month or longer.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
This study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood.
Read the 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.
- Conditions
- Insomnia, Sleep Problem
- Being tested
- 8-ounce glass of cherry juice, Artificial Cherry Juice
- Keywords
- Cherry Juice Pilot
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-ounce glass of cherry juiceOther
You will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory.
Artificial Cherry JuiceOther
You will be given an 8-ounce glass of artificial cherry juice
| Study group | Role | What they receive |
|---|---|---|
| Cherry Juice Standardized | Experimental | You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory. Receives: Other: 8-ounce glass of cherry juice; Other: Artificial Cherry Juice |
| Artificial Cherry Juice | Placebo comparator | You will be given an 8-ounce glass of artificial cherry juice to drink when you arrive at the Sleep Laboratory. Receives: Other: 8-ounce glass of cherry juice; Other: Artificial Cherry Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the polysomnography of participants with insomnia
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.
Measured: Baseline and Week 4
Secondary outcomes (3)
Compare the Insomnia Severity Index and validated questionnaires
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.
Measured: Baseline and Week 4
Comparison of insomnia sleep scales
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.
Measured: Baseline and Week 4
Differences in the enzyme blood test
compare the expression of enzyme blood test of participants taking the standardized cherry juice vs. the the placebo juice.
Measured: Baseline, Week 2 & Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Grower's Association
- Responsible party
- Principal investigator, Frank Greenway, Pennington Biomedical Research Center
- Investigators
- Frank Greenway, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669317
- Sponsor's protocol ID
- PBRC 12004
- Acronym
- CHERRY JUICE
- Status last verified
- Dec 2015
- First submitted
- 14 Aug 2012
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content
- ClinicalTrials.gov ID
- NCT01669317
- Acronym / sponsor ID
- CHERRY JUICE / PBRC 12004
- Conditions
- Insomnia, Sleep Problem
- Keywords
- Cherry Juice Pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- Cherry Grower's Association
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Aug 2012 (estimated)
- 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.
This study is designed to demonstrate that cherry juice is effective in treating insomnia, and to show that it works by inhibiting an enzyme that will be measured in the blood.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cherry Juice Standardized | Experimental | Other: 8-ounce glass of cherry juice, Other: Artificial Cherry JuiceYou will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory. |
| Artificial Cherry Juice | Placebo comparator | Other: 8-ounce glass of cherry juice, Other: Artificial Cherry JuiceYou will be given an 8-ounce glass of artificial cherry juice to drink when you arrive at the Sleep Laboratory. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- 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).
- 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.
Key exclusion criteria (3 listed)
- Diabetes.
- Sedating or hypnotic medications.
- Any chronic medication that has not had a stable dose for 1 month or longer.
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 |
|---|---|---|
| 8-ounce glass of cherry juiceYou will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory. | Other | Artificial Cherry Juice, Cherry Juice Standardized |
| Artificial Cherry JuiceYou will be given an 8-ounce glass of artificial cherry juice | Other | Artificial Cherry Juice, Cherry Juice Standardized |
Primary outcome
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.
3 secondary outcomes
Compare the Insomnia Severity Index and validated questionnaires
Time frame: Baseline and Week 4
Comparison of insomnia sleep scales
Time frame: Baseline and Week 4
Differences in the enzyme blood test
Time frame: Baseline, Week 2 & Week 4
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 18 Dec 2015.
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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.
Frank Greenway, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-ounce glass of cherry juice and Artificial Cherry Juice in people with Insomnia and Sleep Problem, run by Pennington Biomedical Research Center 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 17 inclusion and 3 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 18 Dec 2015. 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?
Compare the polysomnography of participants with insomnia (time frame: Baseline and Week 4). 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 18 Dec 2015.