The Sleep Improving Effects of Orange Phenolics

November 19, 2015 updated by: Maastricht University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229
        • Maastricht University Medical Center (MUMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO)
Time Frame: 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.
9 test nights (up to 9 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires
Time Frame: up to 9 days. Questionnaires are filled out the morning after every test night
Leeds Sleep Evaluation Questionnaire
up to 9 days. Questionnaires are filled out the morning after every test night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

November 19, 2015

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL43845.068.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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