Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes
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.
Investigators
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)