Sleep DisturbanceNCT06239168
Citrus Extract, Sleep and Mental Wellbeing
A study testing Citrus extract and Maltodextrin in people with Sleep Disturbance, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance
- What is being tested?
- Citrus extract and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2023to Dec 2024
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy individuals with (minor) sleep disturbance
- Age 40-70 years
- BMI 18.5 - 30 kg/m2
- Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study
Who cannot join
- Excessive caffeine use
- Major psychiatric/mental health disorders .
- Chronic sleep disorders
- Severe sleep disturbance for more than 1 year
- Other clear causes for poor sleep quality or mental wellbeing
- Use of medication or supplements that can affect outcomes
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- Nonpharmacological treatment for sleep disorders
- Flight from a time-zone with >3 h difference ≤1 week before an intervention period
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study
- Use of pre-, pro- or synbiotics within 1 month prior to the start of the study
- Reported weight loss or weight gain of >3 kg in the month prior to pre-study screening
- Smoking
- Abuse of products
- Known allergy to citruses
- Known pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht
Yala Stevens, PhD, +31437114555, yala.stevens@maastrichtuniversity.nl
Jogchum Plat, Prof
About this study
Official title: The Effect of Citrus Extract on Sleep and Mental Wellbeing
This is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.
Read the detailed description
Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.
- Conditions
- Sleep Disturbance
- Being tested
- Citrus extract, Maltodextrin
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citrus extractDietary supplement
As described in experimental arm
MaltodextrinDietary supplement
As described in comparator arm
| Study group | Role | What they receive |
|---|---|---|
| Citrus extract | Experimental | Daily Citrus extract supplementation for 8 weeks. Receives: Dietary Supplement: Citrus extract |
| Control | Placebo comparator | Daily Maltodextrin supplementation for 8 weeks. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep quality scores between the intervention and placebo group
Measured by a sleep quality questionnaire (PSQI)
Measured: 8 weeks of intervention
Changes in sleep quality between the intervention and placebo group
Measured using actigraphy
Measured: 8 weeks of intervention
Secondary outcomes (1)
Changes in mental wellbeing between the intervention and placebo group
Measured by mental wellbeing questionnaires
Measured: 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start8 Nov 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioActor
- Responsible party
- Sponsor
- Investigators
- Jogchum Plat, Principal investigator, Maastricht UniversityTanja Adam, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239168
- Sponsor's protocol ID
- 23-012
- Status last verified
- Jan 2024
- First submitted
- 14 Dec 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Citrus Extract on Sleep and Mental Wellbeing
- ClinicalTrials.gov ID
- NCT06239168
- Acronym / sponsor ID
- 23-012
- Conditions
- Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- BioActor
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Feb 2024 (actual)
- 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 is a randomized, double-blind, placebo-controlled, cross-over trial investigating the effects of daily administration of citrus extract on sleep and mental wellbeing.
Detailed description
Based on epidemiological data, a substantial number of people report to have sleeping problems. This is of major concern, as poor sleep quality has been associated with impaired mental and physical health. Several pre-clinical studies have shown promising results, but evidence from human studies is still limited. Therefore, the aim of the present study is to investigate the effect of a citrus extract on sleep and mental wellbeing in healthy subjects with (minor) sleep disturbance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrus extract | Experimental | Dietary Supplement: Citrus extractDaily Citrus extract supplementation for 8 weeks. |
| Control | Placebo comparator | Dietary Supplement: MaltodextrinDaily Maltodextrin supplementation for 8 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy individuals with (minor) sleep disturbance
- Age 40-70 years
- BMI 18.5 - 30 kg/m2
- Willingness to give up being a blood donor from 4 weeks before the start of the study, during the study and for 4 weeks after completion of the study
Key exclusion criteria (15 listed)
- Excessive caffeine use
- Major psychiatric/mental health disorders .
- Chronic sleep disorders
- Severe sleep disturbance for more than 1 year
- Other clear causes for poor sleep quality or mental wellbeing
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 |
|---|---|---|
| Citrus extractAs described in experimental arm | Dietary supplement | Citrus extract |
| MaltodextrinAs described in comparator arm | Dietary supplement | Control |
Primary outcome
Changes in sleep quality scores between the intervention and placebo group
Time frame: 8 weeks of intervention
Measured by a sleep quality questionnaire (PSQI)
Changes in sleep quality between the intervention and placebo group
Time frame: 8 weeks of intervention
Measured using actigraphy
1 secondary outcome
Changes in mental wellbeing between the intervention and placebo group
Time frame: 8 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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.
Jogchum Plat principal investigator
Maastricht University
Tanja Adam principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citrus extract and Maltodextrin in people with Sleep Disturbance, 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 15 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yala Stevens, PhD (+31437114555, yala.stevens@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in sleep quality scores between the intervention and placebo group (time frame: 8 weeks of intervention). The study lists 2 primary outcomes in all. 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 2 Feb 2024.