The Sleep Improving Effects of Orange Phenolics

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02209103

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

12.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Polyphenols Sleep Fatigue	Dietary Supplement: Lozenge containing citrus flavonoid Dietary Supplement: Lozenge containing citrus flavonoid formulation Dietary Supplement: Identical looking placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

77 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Citrus flavonoid Citrus flavonoid	Dietary Supplement: Lozenge containing citrus flavonoid
Experimental: Citrus flavonoid formulation Citrus flavonoid formulation	Dietary Supplement: Lozenge containing citrus flavonoid formulation
Placebo Comparator: Placebo Placebo	Dietary Supplement: Identical looking placebo

Arm

Intervention/Treatment

Experimental: Citrus flavonoid

Citrus flavonoid

Dietary Supplement: Lozenge containing citrus flavonoid

Experimental: Citrus flavonoid formulation

Citrus flavonoid formulation

Dietary Supplement: Lozenge containing citrus flavonoid formulation

Placebo Comparator: Placebo

Placebo

Dietary Supplement: Identical looking placebo

Outcome Measures

Primary Outcome Measures

Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO) [9 test nights (up to 9 days)]
• 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 [up to 9 days. Questionnaires are filled out the morning after every test night]
Leeds Sleep Evaluation Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University Medical Center (MUMC)	Maastricht		Netherlands	6229

Sponsors and Collaborators

Maastricht University Medical Center

Investigators

Principal Investigator: Chris Van der Grinten, Department: lung diseases MUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maastricht University Medical Center

ClinicalTrials.gov Identifier:

NCT02209103

Other Study ID Numbers:

NL43845.068.13

First Posted:

Aug 5, 2014

Last Update Posted:

Nov 20, 2015

Last Verified:

Aug 1, 2014

Keywords provided by Maastricht University Medical Center

Additional relevant MeSH terms:

Fatigue

Study Results

No Results Posted as of Nov 20, 2015