The Sleep Improving Effects of Orange Phenolics

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209103
• Other study ID #: NL43845.068.13
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: November 19, 2015
• Start date: March 2014
• Est. completion date: September 2014

Study information

• Verified date: August 2014
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue
• Polyphenols
• Sleep

Intervention

Dietary Supplement:
• Lozenge containing citrus flavonoid

• Lozenge containing citrus flavonoid formulation

• Identical looking placebo

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center (MUMC)	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 test nights (up to 9 days)	No
Secondary	Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires	Leeds Sleep Evaluation Questionnaire	up to 9 days. Questionnaires are filled out the morning after every test night	No