The Sleep Improving Effects of Orange Phenolics

NCT ID: NCT02209103

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Polyphenols Sleep Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Citrus flavonoid

Citrus flavonoid

Group Type EXPERIMENTAL

Lozenge containing citrus flavonoid

Intervention Type DIETARY_SUPPLEMENT

Citrus flavonoid formulation

Citrus flavonoid formulation

Group Type EXPERIMENTAL

Lozenge containing citrus flavonoid formulation

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Identical looking placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Lozenge containing citrus flavonoid

Intervention Type DIETARY_SUPPLEMENT

Lozenge containing citrus flavonoid formulation

Intervention Type DIETARY_SUPPLEMENT

Identical looking placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chris Van der Grinten

Role: PRINCIPAL_INVESTIGATOR

Department: lung diseases MUMC

Locations

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Maastricht University Medical Center (MUMC)

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL43845.068.13

Identifier Type: -

Identifier Source: org_study_id