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

Primary Purpose

Insomnia, Sleep Problem

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

8-ounce glass of cherry juice

Artificial Cherry Juice

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Cherry Juice Pilot

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cherry Juice Standardized

Artificial Cherry Juice

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT01669317

First Posted

August 14, 2012

Last Updated

December 17, 2015

Sponsor

Pennington Biomedical Research Center

Collaborators

Cherry Grower's Association

1. Study Identification

Unique Protocol Identification Number

NCT01669317

Brief Title

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

Acronym

CHERRY JUICE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pennington Biomedical Research Center

Collaborators

Cherry Grower's Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Sleep Problem

Keywords

Cherry Juice Pilot

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cherry Juice Standardized

Arm Type

Experimental

Arm Description

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

Arm Title

Artificial Cherry Juice

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

8-ounce glass of cherry juice

Intervention Description

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

Intervention Name(s)

Artificial Cherry Juice

Intervention Description

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

Primary Outcome Measure Information:

Title

Compare the polysomnography of participants with insomnia

Description

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.

Time Frame

Baseline and Week 4

Secondary Outcome Measure Information:

Title

Compare the Insomnia Severity Index and validated questionnaires

Description

Time Frame

Baseline and Week 4

Title

Comparison of insomnia sleep scales

Description

Time Frame

Baseline and Week 4

Title

Differences in the enzyme blood test

Description

compare the expression of enzyme blood test of participants taking the standardized cherry juice vs. the the placebo juice.

Time Frame

Baseline, Week 2 & Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Greenway, MD

Organizational Affiliation

Study Principal Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Pennington Biomedical Research Center

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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