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Completed

NCT Number: NCT05700643

Montmorency Cherry Supplementation, Sleep, and Inflammation

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

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Key information

Conditions

Insomnia Chronic Dyssomnias Inflammation Mental Disorders Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Michigan State University

East Lansing, Michigan, 48824, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montmorency cherry supplement

Dietary Supplement

Montmorency cherry supplement

Control

Dietary Supplement

Placebo

Primary outcomes

  1. Change in total sleep time

    Time frame: Through study completion, two weeks for each arm

    sleep duration in hours and minutes

  2. 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

  3. 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

Secondary outcomes

  1. Change in C-reactive protein

    Time frame: Through study completion, two weeks for each arm

    blood work

  2. Change in Interleukin-6

    Time frame: Through study completion, two weeks for each arm

    blood work

  3. Change in Interleukin-8

    Time frame: Through study completion, two weeks for each arm

    blood work

  4. Change in Interleukin-17

    Time frame: Through study completion, two weeks for each arm

    blood work

  5. Change in Tumor necrosis factor-alpha

    Time frame: Through study completion, two weeks for each arm

    blood work

  6. Change in Anthropometrics

    Time frame: Through study completion, two weeks for each arm

    Percent body fat

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Cherry Marketing Institute

Registry information

Official study title

Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 26, 2023
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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