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

Insomnia Clinical Trial

— CHERRY JUICE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01669317
• Other study ID #: PBRC 12004
• Status: Completed
• Phase: N/A
• First received: August 14, 2012
• Last updated: December 17, 2015
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disorders
• Sleep Problem

Intervention

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.
• Artificial Cherry Juice
You will be given an 8-ounce glass of artificial cherry juice

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Cherry Grower’s Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No