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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep Problem
• Intervention / Treatment: Other: 8-ounce glass of cherry juice; Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Week 2 & Week 4

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Collaborators: Cherry Grower's Association
• Investigators: Principal Investigator: Frank Greenway, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 14, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Cherry Juice Pilot
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: PBRC 12004