Montmorency Cherry Supplementation, Sleep, and Inflammation

September 4, 2025 updated by: Robin Tucker, Michigan State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • unwilling or unable to stop the use of sleep medication
  • unable to attend laboratory visits on the East Lansing, Michigan campus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Placebo
Dietary supplement: Control
Placebo
Experimental: Intervention
500 mg cherry supplement
Dietary supplement: Montmorency cherry supplement
Montmorency cherry supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in total sleep time
Time Frame: Through study completion, two weeks for each arm
sleep duration in hours and minutes
Through study completion, two weeks for each arm
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
Through study completion, two weeks for each arm
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
Through study completion, two weeks for each arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in C-reactive protein
Time Frame: Through study completion, two weeks for each arm
blood work
Through study completion, two weeks for each arm
Change in Interleukin-6
Time Frame: Through study completion, two weeks for each arm
blood work
Through study completion, two weeks for each arm
Change in Interleukin-8
Time Frame: Through study completion, two weeks for each arm
blood work
Through study completion, two weeks for each arm
Change in Interleukin-17
Time Frame: Through study completion, two weeks for each arm
blood work
Through study completion, two weeks for each arm
Change in Tumor necrosis factor-alpha
Time Frame: Through study completion, two weeks for each arm
blood work
Through study completion, two weeks for each arm
Change in Anthropometrics
Time Frame: Through study completion, two weeks for each arm
Percent body fat
Through study completion, two weeks for each arm

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Collaborators

Cherry Marketing Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2023

Primary Completion (Actual)

April 17, 2024

Study Completion (Actual)

April 17, 2024

Study Registration Dates

First Submitted

December 7, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate data available upon request upon completion of analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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