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Montmorency Cherry Supplementation, Sleep, and Inflammation

Primary Purpose

Insomnia Chronic, Inflammation

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Montmorency cherry supplement
Control
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    500 mg cherry supplement

    Placebo

    Outcomes

    Primary Outcome Measures

    Change in total sleep time
    sleep duration in hours and minutes
    Change in sleep quality
    Pittsburgh Sleep Quality Index scores, scores range from 0-21, higher scores indicate worse outcomes
    Change in insomnia symptoms
    Insomnia Severity Index scores, scores range from 0-28, higher scores indicate worse outcomes

    Secondary Outcome Measures

    Change in C-reactive protein
    blood work
    Change in Interleukin-6
    blood work
    Change in Interleukin-8
    blood work
    Change in Interleukin-17
    blood work
    Change in Tumor necrosis factor-alpha
    blood work
    Change in Anthropometrics
    Percent body fat

    Full Information

    First Posted
    December 7, 2022
    Last Updated
    January 17, 2023
    Sponsor
    Michigan State University
    Collaborators
    Cherry Marketing Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05700643
    Brief Title
    Montmorency Cherry Supplementation, Sleep, and Inflammation
    Official Title
    Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 18, 2023 (Anticipated)
    Primary Completion Date
    January 17, 2024 (Anticipated)
    Study Completion Date
    January 17, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Michigan State University
    Collaborators
    Cherry Marketing Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia Chronic, Inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    500 mg cherry supplement
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Montmorency cherry supplement
    Intervention Description
    Montmorency cherry supplement
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Control
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Change in total sleep time
    Description
    sleep duration in hours and minutes
    Time Frame
    Through study completion, two weeks for each arm
    Title
    Change in sleep quality
    Description
    Pittsburgh Sleep Quality Index scores, scores range from 0-21, higher scores indicate worse outcomes
    Time Frame
    Through study completion, two weeks for each arm
    Title
    Change in insomnia symptoms
    Description
    Insomnia Severity Index scores, scores range from 0-28, higher scores indicate worse outcomes
    Time Frame
    Through study completion, two weeks for each arm
    Secondary Outcome Measure Information:
    Title
    Change in C-reactive protein
    Description
    blood work
    Time Frame
    Through study completion, two weeks for each arm
    Title
    Change in Interleukin-6
    Description
    blood work
    Time Frame
    Through study completion, two weeks for each arm
    Title
    Change in Interleukin-8
    Description
    blood work
    Time Frame
    Through study completion, two weeks for each arm
    Title
    Change in Interleukin-17
    Description
    blood work
    Time Frame
    Through study completion, two weeks for each arm
    Title
    Change in Tumor necrosis factor-alpha
    Description
    blood work
    Time Frame
    Through study completion, two weeks for each arm
    Title
    Change in Anthropometrics
    Description
    Percent body fat
    Time Frame
    Through study completion, two weeks for each arm

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Robin Tucker, PhD
    Phone
    517-353-3408
    Email
    tucker98@msu.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Aggregate data available upon request upon completion of analysis.

    Learn more about this trial

    Montmorency Cherry Supplementation, Sleep, and Inflammation

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