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Clinical Trials/NCT05700643
NCT05700643
Completed
Phase 1

Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes

Michigan State University1 site in 1 country34 target enrollmentFebruary 18, 2023

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Insomnia Chronic
Sponsor
Michigan State University
Enrollment
34
Locations
1
Primary Endpoint
Change in insomnia symptoms
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
February 18, 2023
End Date
April 17, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robin Tucker

Associate Professor

Michigan State University

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

Outcomes

Primary 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

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

Secondary Outcomes

  • Change in Interleukin-8(Through study completion, two weeks for each arm)
  • Change in Interleukin-17(Through study completion, two weeks for each arm)
  • Change in Tumor necrosis factor-alpha(Through study completion, two weeks for each arm)
  • Change in Interleukin-6(Through study completion, two weeks for each arm)
  • Change in C-reactive protein(Through study completion, two weeks for each arm)
  • Change in Anthropometrics(Through study completion, two weeks for each arm)

Study Sites (1)

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