Montmorency Cherry Supplementation, Sleep, and Inflammation

Inflammation Clinical Trial

Official title:

Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05700643
• Other study ID #: STUDY00008275
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: February 18, 2023
• Est. completion date: April 17, 2024

Study information

• Verified date: February 2024
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: April 17, 2024
• Est. primary completion date: April 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Insomnia Chronic

Intervention

Dietary Supplement:
• Montmorency cherry supplement
Montmorency cherry supplement
• Control
Placebo

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Cherry Marketing Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total sleep time	sleep duration in hours and minutes	Through study completion, two weeks for each arm
Primary	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
Primary	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	Change in C-reactive protein	blood work	Through study completion, two weeks for each arm
Secondary	Change in Interleukin-6	blood work	Through study completion, two weeks for each arm
Secondary	Change in Interleukin-8	blood work	Through study completion, two weeks for each arm
Secondary	Change in Interleukin-17	blood work	Through study completion, two weeks for each arm
Secondary	Change in Tumor necrosis factor-alpha	blood work	Through study completion, two weeks for each arm
Secondary	Change in Anthropometrics	Percent body fat	Through study completion, two weeks for each arm