Insomnia ChronicPhase 1/2NCT05700643
Montmorency Cherry Supplementation, Sleep, and Inflammation
A Phase 1/2 study testing Montmorency cherry supplement in people with Insomnia Chronic and Inflammation, run by Michigan State University at 1 site in United States.
Trial summary
This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia Chronic, Inflammation
- What is being tested?
- Montmorency cherry supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2023to 17 Apr 2024
- Phase
- Phase 1/2
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- body mass index (BMI) of ≥ 25.0 kg/m2;
- sleep issues as identified by a global score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI) and/or a score 8 or higher on the Insomnia Severity Index (ISI);
- ability to adhere to a diet low in antioxidants during the study period; and
- willingness to wear a Fitbit for the duration of the study and to wear the Zmachine on selected nights.
Who cannot join
- unwilling or unable to stop the use of sleep medication
- unable to attend laboratory visits on the East Lansing, Michigan campus
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
Official title: Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes
This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.
- Conditions
- Insomnia Chronic, Inflammation
- Being tested
- Montmorency cherry supplement, Control
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montmorency cherry supplementDietary supplement
Montmorency cherry supplement
ControlDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 500 mg cherry supplement Receives: Dietary Supplement: Montmorency cherry supplement |
| Control | Placebo comparator | Placebo Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep time
sleep duration in hours and minutes
Measured: Through study completion, two weeks for each arm
Change in sleep quality
Pittsburgh Sleep Quality Index scores, scores range from 0-21, higher scores indicate worse outcomes
Measured: Through study completion, two weeks for each arm
Change in insomnia symptoms
Insomnia Severity Index scores, scores range from 0-28, higher scores indicate worse outcomes
Measured: Through study completion, two weeks for each arm
Secondary outcomes (6)
Change in C-reactive protein
blood work
Measured: Through study completion, two weeks for each arm
Change in Interleukin-6
blood work
Measured: Through study completion, two weeks for each arm
Change in Interleukin-8
blood work
Measured: Through study completion, two weeks for each arm
Change in Interleukin-17
blood work
Measured: Through study completion, two weeks for each arm
Change in Tumor necrosis factor-alpha
blood work
Measured: Through study completion, two weeks for each arm
Change in Anthropometrics
Percent body fat
Measured: Through study completion, two weeks for each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start18 Feb 2023
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Cherry Marketing Institute
- Responsible party
- Principal investigator, Robin Tucker, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700643
- Sponsor's protocol ID
- STUDY00008275
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2022
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data available upon request upon completion of analysis.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes
- ClinicalTrials.gov ID
- NCT05700643
- Acronym / sponsor ID
- STUDY00008275
- Conditions
- Insomnia Chronic, Inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Cherry Marketing Institute
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 26 Jan 2023 (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 study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Montmorency cherry supplement500 mg cherry supplement |
| Control | Placebo comparator | Dietary Supplement: ControlPlacebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- body mass index (BMI) of ≥ 25.0 kg/m2;
- sleep issues as identified by a global score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI) and/or a score 8 or higher on the Insomnia Severity Index (ISI);
- ability to adhere to a diet low in antioxidants during the study period; and
- willingness to wear a Fitbit for the duration of the study and to wear the Zmachine on selected nights.
Key exclusion criteria (2 listed)
- unwilling or unable to stop the use of sleep medication
- unable to attend laboratory visits on the East Lansing, Michigan campus
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 |
|---|---|---|
| Montmorency cherry supplementMontmorency cherry supplement | Dietary supplement | Intervention |
| ControlPlacebo | Dietary supplement | Control |
Primary outcome
Change in total sleep time
Time frame: Through study completion, two weeks for each arm
sleep duration in hours and minutes
Change in sleep quality
Time frame: Through study completion, two weeks for each arm
Pittsburgh Sleep Quality Index scores, scores range from 0-21, higher scores indicate worse outcomes
Change in insomnia symptoms
Time frame: Through study completion, two weeks for each arm
Insomnia Severity Index scores, scores range from 0-28, higher scores indicate worse outcomes
6 secondary outcomes
Change in C-reactive protein
Time frame: Through study completion, two weeks for each arm
Change in Interleukin-6
Time frame: Through study completion, two weeks for each arm
Change in Interleukin-8
Time frame: Through study completion, two weeks for each arm
Change in Interleukin-17
Time frame: Through study completion, two weeks for each arm
Change in Tumor necrosis factor-alpha
Time frame: Through study completion, two weeks for each arm
Change in Anthropometrics
Time frame: Through study completion, two weeks for each arm
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 8 Sep 2025.
- Individual participant dataSharing planned: No. Aggregate data available upon request upon completion of analysis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Montmorency cherry supplement in people with Insomnia Chronic and Inflammation, run by Michigan State University at 1 site in United States.
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 2 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 8 Sep 2025. 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 United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in total sleep time (time frame: Through study completion, two weeks for each arm). The study lists 3 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 8 Sep 2025.