Montmorency Cherry Supplementation, Sleep, and Inflammation

NCT ID: NCT05700643

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-18

Study Completion Date

2024-04-17

Brief Summary

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This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.

Detailed Description

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Conditions

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Insomnia Chronic Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Intervention

500 mg cherry supplement

Group Type EXPERIMENTAL

Montmorency cherry supplement

Intervention Type DIETARY_SUPPLEMENT

Montmorency cherry supplement

Control

Placebo

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Montmorency cherry supplement

Montmorency cherry supplement

Intervention Type DIETARY_SUPPLEMENT

Control

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cherry Marketing Institute

UNKNOWN

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Robin Tucker

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00008275

Identifier Type: -

Identifier Source: org_study_id

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