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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02209103
Other study ID # NL43845.068.13
Secondary ID
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


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
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