Montmorency Cherry Supplementation, Sleep, and Inflammation

Phase 1

Active, not recruiting

• Conditions: Insomnia Chronic; Inflammation
• Interventions: Dietary Supplement: Control; Dietary Supplement: Montmorency cherry supplement

• Registration Number: NCT05700643
• Lead Sponsor: Michigan State University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-26
• Study Start: 2023-02-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-04-17
• Study Completion: 2024-04-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Control	Placebo
Intervention	Montmorency cherry supplement	500 mg cherry supplement

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
Change in Interleukin-8	Through study completion, two weeks for each arm	blood work
Change in Interleukin-17	Through study completion, two weeks for each arm	blood work
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 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

Trial Locations

Locations (1)

Michigan State University; 🇺🇸 East Lansing, Michigan, United States