The Sleep Improving Effects of Orange Phenolics

NCT02209103 | Completed DMC

• 1 other identifier: NL43845.068.13
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polyphenols; Sleep; Fatigue

Keywords

Polyphenols; Orange; Sleep; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires

  up to 9 days. Questionnaires are filled out the morning after every test night

Study Arms (3)

Citrus flavonoid

EXPERIMENTAL

Citrus flavonoid

Dietary Supplement: Lozenge containing citrus flavonoid

Citrus flavonoid formulation

EXPERIMENTAL

Citrus flavonoid formulation

Dietary Supplement: Lozenge containing citrus flavonoid formulation

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Identical looking placebo

Interventions

Lozenge containing citrus flavonoid DIETARY_SUPPLEMENT

Citrus flavonoid

Lozenge containing citrus flavonoid formulation DIETARY_SUPPLEMENT

Citrus flavonoid formulation

Identical looking placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75
• Non-smoking
• Healthy
• Lightly disturbed sleep for at least six months, on a regular basis

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center (MUMC)

Maastricht, 6229, Netherlands

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Van der Grinten

  Department: lung diseases MUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 5, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 20, 2015

Record last verified: 2014-08

Locations

NL (1)