PolyphenolsNCT02209103
The Sleep Improving Effects of Orange Phenolics
A study testing Lozenge containing citrus flavonoid and Lozenge containing citrus flavonoid formulation in people with Polyphenols and Sleep, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Polyphenols, Sleep, Fatigue
- What is being tested?
- Lozenge containing citrus flavonoid and Lozenge containing citrus flavonoid formulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- Non-smoking
- Healthy
- Lightly disturbed sleep for at least six months, on a regular basis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center (MUMC)
Maastricht, 6229
About this study
Official title: Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract
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
- Being tested
- Lozenge containing citrus flavonoid, Lozenge containing citrus flavonoid formulation, Identical looking placebo
- Keywords
- Polyphenols, Orange, Sleep, Fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lozenge containing citrus flavonoidDietary supplement
Lozenge containing citrus flavonoid formulationDietary supplement
Identical looking placeboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Citrus flavonoid | Experimental | Citrus flavonoid Receives: Dietary Supplement: Lozenge containing citrus flavonoid |
| Citrus flavonoid formulation | Experimental | Citrus flavonoid formulation Receives: Dietary Supplement: Lozenge containing citrus flavonoid formulation |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Identical looking placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 test nights (up to 9 days)
Secondary outcomes (1)
Subjective sleep quality ratings and fitness, tiredness and cognitive ratings, obtained from questionnaires
Leeds Sleep Evaluation Questionnaire
Measured: up to 9 days. Questionnaires are filled out the morning after every test night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startMar 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyphenolsStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Van der Grinten, Principal investigator, Department: lung diseases MUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209103
- Sponsor's protocol ID
- NL43845.068.13
- Status last verified
- Aug 2014
- First submitted
- 4 Aug 2014
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Sleep Improving Effects of Phenolics From an Orange Peel Extract
- ClinicalTrials.gov ID
- NCT02209103
- Acronym / sponsor ID
- NL43845.068.13
- Conditions
- Polyphenols, Sleep, Fatigue
- Keywords
- Polyphenols, Orange, Sleep, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Citrus flavonoid | Experimental | Dietary Supplement: Lozenge containing citrus flavonoidCitrus flavonoid |
| Citrus flavonoid formulation | Experimental | Dietary Supplement: Lozenge containing citrus flavonoid formulationCitrus flavonoid formulation |
| Placebo | Placebo comparator | Dietary Supplement: Identical looking placeboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75
- Non-smoking
- Healthy
- Lightly disturbed sleep for at least six months, on a regular basis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lozenge containing citrus flavonoid | Dietary supplement | Citrus flavonoid |
| Lozenge containing citrus flavonoid formulation | Dietary supplement | Citrus flavonoid formulation |
| Identical looking placebo | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Van der Grinten principal investigator
Department: lung diseases MUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lozenge containing citrus flavonoid and Lozenge containing citrus flavonoid formulation in people with Polyphenols and Sleep, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality as assessed objectively by means of a portable sleep monitoring system (ZEO) (time frame: 9 test nights (up to 9 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2015.