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

NCT ID: NCT01669317

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-10-31

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.

Conditions

Insomnia; Sleep Problem

Keywords

Cherry Juice Pilot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cherry Juice Standardized

You will be given an 8-ounce glass of cherry juice to drink when you arrive at the Sleep Laboratory.

Group Type: EXPERIMENTAL

8-ounce glass of cherry juice

Intervention Type: OTHER

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

Intervention Type: OTHER

You will be given an 8-ounce glass of artificial cherry juice

Artificial Cherry Juice

You will be given an 8-ounce glass of artificial cherry juice to drink when you arrive at the Sleep Laboratory.

Group Type: PLACEBO_COMPARATOR

8-ounce glass of cherry juice

Intervention Type: OTHER

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

Intervention Type: OTHER

You will be given an 8-ounce glass of artificial cherry juice

Interventions

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.

Intervention Type: OTHER

Artificial Cherry Juice

You will be given an 8-ounce glass of artificial cherry juice

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cherry Grower's Association

UNKNOWN

Sponsor Role: collaborator

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Frank Greenway

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Greenway, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC 12004

Identifier Type: -

Identifier Source: org_study_id