Skip to main content
OpenTrials
Completed

NCT Number: NCT02209103

The Sleep Improving Effects of Orange Phenolics

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polyphenols Fatigue Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center (MUMC)

Maastricht, 6229, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lozenge containing citrus flavonoid

Dietary Supplement

Lozenge containing citrus flavonoid formulation

Dietary Supplement

Identical looking placebo

Dietary Supplement

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 5, 2014
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.