Inflammation, Insomnia Chronic
Conditions
Brief summary
This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.
Interventions
DIETARY_SUPPLEMENTMontmorency cherry supplement
Montmorency cherry supplement
DIETARY_SUPPLEMENTControl
Placebo
Sponsors
Cherry Marketing Institute
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total sleep time | Through study completion, two weeks for each arm | sleep duration in hours and minutes |
| Change in sleep quality | Through study completion, two weeks for each arm | Pittsburgh Sleep Quality Index scores, scores range from 0-21, higher scores indicate worse outcomes |
| Change in insomnia symptoms | Through study completion, two weeks for each arm | Insomnia Severity Index scores, scores range from 0-28, higher scores indicate worse outcomes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Interleukin-17 | Through study completion, two weeks for each arm | blood work |
| Change in C-reactive protein | Through study completion, two weeks for each arm | blood work |
| Change in Anthropometrics | Through study completion, two weeks for each arm | Percent body fat |
| Change in Tumor necrosis factor-alpha | Through study completion, two weeks for each arm | blood work |
| Change in Interleukin-6 | Through study completion, two weeks for each arm | blood work |
| Change in Interleukin-8 | Through study completion, two weeks for each arm | blood work |
Countries
United States
Outcome results
None listed