Montmorency Cherry Supplementation, Sleep, and Inflammation

Michigan State University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Inflammation; Insomnia Chronic

Treatments: Dietary Supplement: Control; Dietary Supplement: Montmorency cherry supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05700643

STUDY00008275

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

500 mg cherry supplement

Treatment:

Dietary Supplement: Montmorency cherry supplement

Control

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Control