The Sleep Improving Effects of Orange Phenolics
Primary Purpose
Polyphenols, Sleep, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Lozenge containing citrus flavonoid
Lozenge containing citrus flavonoid formulation
Identical looking placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Polyphenols focused on measuring Polyphenols, Orange, Sleep, Fatigue
Eligibility Criteria
Inclusion Criteria:
- Age 18-75
- Non-smoking
- Healthy
- Lightly disturbed sleep for at least six months, on a regular basis
Exclusion Criteria:
- Severe sleep disorders (sleep apnea, restless legs syndrome)
- An apparent cause for the sleep disorders (pain, etc.)
- Clinically significant abnormal liver functioning
- Clinically significant abnormal serum creatinine
- BMI lower than 18 or higher than 30 kg/m2
- Use of concomitant medications or supplements
Sites / Locations
- Maastricht University Medical Center (MUMC)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Citrus flavonoid
Citrus flavonoid formulation
Placebo
Arm Description
Citrus flavonoid
Citrus flavonoid formulation
Placebo
Outcomes
Primary Outcome Measures
Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)
• The primary endpoint for this study is the determination of sleep quality, as assessed objectively with the portable sleep monitoring system ZEO, which is based on EEG/EMG (electromyography) coupled with an automatic sleep phase classifier. Sleep stages are classified as deep sleep, light sleep, REM (rapid eye movement) sleep or awake. The sleep patterns of the participants after ingestion of the two different test products will be compared to each other and to placebo.
Secondary Outcome Measures
Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires
Leeds Sleep Evaluation Questionnaire
Full Information
NCT ID
NCT02209103
First Posted
August 4, 2014
Last Updated
November 19, 2015
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02209103
Brief Title
The Sleep Improving Effects of Orange Phenolics
Official Title
Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can improve objective sleep duration and/or quality, and/or improve perceived sleep quality and feelings of rest.
Participants will complete a total of 9 test nights, which consist of sleeping with the sleep monitoring system after ingestion of the test product or a placebo, and filling out sleep-related questionnaires.
The study has a crossover design, meaning that all participants receive all three interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a randomized order.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyphenols, Sleep, Fatigue
Keywords
Polyphenols, Orange, Sleep, Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Citrus flavonoid
Arm Type
Experimental
Arm Description
Citrus flavonoid
Arm Title
Citrus flavonoid formulation
Arm Type
Experimental
Arm Description
Citrus flavonoid formulation
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lozenge containing citrus flavonoid
Intervention Type
Dietary Supplement
Intervention Name(s)
Lozenge containing citrus flavonoid formulation
Intervention Type
Dietary Supplement
Intervention Name(s)
Identical looking placebo
Primary Outcome Measure Information:
Title
Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)
Description
• The primary endpoint for this study is the determination of sleep quality, as assessed objectively with the portable sleep monitoring system ZEO, which is based on EEG/EMG (electromyography) coupled with an automatic sleep phase classifier. Sleep stages are classified as deep sleep, light sleep, REM (rapid eye movement) sleep or awake. The sleep patterns of the participants after ingestion of the two different test products will be compared to each other and to placebo.
Time Frame
9 test nights (up to 9 days)
Secondary Outcome Measure Information:
Title
Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires
Description
Leeds Sleep Evaluation Questionnaire
Time Frame
up to 9 days. Questionnaires are filled out the morning after every test night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-75
Non-smoking
Healthy
Lightly disturbed sleep for at least six months, on a regular basis
Exclusion Criteria:
Severe sleep disorders (sleep apnea, restless legs syndrome)
An apparent cause for the sleep disorders (pain, etc.)
Clinically significant abnormal liver functioning
Clinically significant abnormal serum creatinine
BMI lower than 18 or higher than 30 kg/m2
Use of concomitant medications or supplements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Van der Grinten
Organizational Affiliation
Department: lung diseases MUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center (MUMC)
City
Maastricht
ZIP/Postal Code
6229
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Sleep Improving Effects of Orange Phenolics
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