Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Pennington Biomedical Research Center
Sponsor:
Collaborator:
Cherry Grower’s Association
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01669317
First received: August 14, 2012
Last updated: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Insomnia
Sleep Problem
Other: 8-ounce glass of cherry juice
Other: Artificial Cherry Juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms Underlying the Sleep Promoting Effect of Cherry Juice Standardized to Its Proanthocyanidin Content

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Compare the polysomnography of participants with insomnia [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Compare the Insomnia Severity Index and validated questionnaires [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    compare the expression of enzyme blood test of participants taking the standardized cherry juice vs. the the placebo juice.


Estimated Enrollment: 10
Study Start Date: June 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cherry Juice Standardized
You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01669317

Locations
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: recruiters    225-763-3000    recruiters@pbrc.edu   
Contact: Greenway       doctors@pbrc.edu   
Principal Investigator: Frank Greenway, MD         
Sub-Investigator: Weihong Pan, MD, PhD         
Sub-Investigator: Jack Losso, PhD         
Sub-Investigator: John Finley, PhD         
Sponsors and Collaborators
Pennington Biomedical Research Center
Cherry Grower’s Association
Investigators
Principal Investigator: Frank Greenway, MD Study Principal Investigator
  More Information

No publications provided

Responsible Party: Frank Greenway, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01669317     History of Changes
Other Study ID Numbers: Cherry Juice Pilot PBRC12004
Study First Received: August 14, 2012
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Cherry Juice Pilot

Additional relevant MeSH terms:
Dyssomnias
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Proanthocyanidin
Procyanidin
Anti-Infective Agents
Antioxidants
Antiparasitic Agents
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014