Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content (CHERRY JUICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01669317
Recruitment Status : Completed
First Posted : August 21, 2012
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
Cherry Grower’s Association
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center

Tracking Information
First Submitted Date  ICMJE August 14, 2012
First Posted Date  ICMJE August 21, 2012
Last Update Posted Date December 18, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01669317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2012)
  • 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.
  • 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.
  • Differences in the enzyme blood test [ Time Frame: Baseline, Week 2 & Week 4 ]
    compare the expression of enzyme blood test of participants taking the standardized cherry juice vs. the the placebo juice.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content
Official Title  ICMJE Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Sleep Problem
Intervention  ICMJE
  • Other: 8-ounce glass of cherry juice
    You 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
    You will be given an 8-ounce glass of artificial cherry juice
Study Arms  ICMJE
  • Experimental: Cherry Juice Standardized
    You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory.
    Interventions:
    • Other: 8-ounce glass of cherry juice
    • Other: Artificial Cherry Juice
  • 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.
    Interventions:
    • Other: 8-ounce glass of cherry juice
    • Other: Artificial Cherry Juice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 16, 2012)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01669317
Other Study ID Numbers  ICMJE PBRC 12004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Frank Greenway, Pennington Biomedical Research Center
Study Sponsor  ICMJE Pennington Biomedical Research Center
Collaborators  ICMJE Cherry Grower’s Association
Investigators  ICMJE
Principal Investigator: Frank Greenway, MD Study Principal Investigator
PRS Account Pennington Biomedical Research Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP