Montmorency Cherry Supplementation, Sleep, and Inflammation

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

Official Title
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Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes

Conditions
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Insomnia Chronic, Inflammation

Intervention / Treatment
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* Dietary Supplement: Montmorency cherry supplement
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>500 mg cherry supplement | Dietary Supplement: Montmorency cherry supplement<br>* Montmorency cherry supplement<br>|
| Placebo Comparator: Control<br>Placebo | Dietary Supplement: Control<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total sleep time | sleep duration in hours and minutes | Through study completion, two weeks for each arm | 
| Change in sleep quality | Pittsburgh Sleep Quality Index scores, scores range from 0-21, higher scores indicate worse outcomes | Through study completion, two weeks for each arm | 
| Change in insomnia symptoms | Insomnia Severity Index scores, scores range from 0-28, higher scores indicate worse outcomes | Through study completion, two weeks for each arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C-reactive protein | blood work | Through study completion, two weeks for each arm | 
| Change in Interleukin-6 | blood work | Through study completion, two weeks for each arm | 
| Change in Interleukin-8 | blood work | Through study completion, two weeks for each arm | 
| Change in Interleukin-17 | blood work | Through study completion, two weeks for each arm | 
| Change in Tumor necrosis factor-alpha | blood work | Through study completion, two weeks for each arm | 
| Change in Anthropometrics | Percent body fat | Through study completion, two weeks for each arm |