Montmorency Cherry Supplementation, Sleep, and Inflammation

NCT05700643 | Completed Phase 1

• 1 other identifier: STUDY00008275
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia Chronic; Inflammation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Change in C-reactive protein

  Through study completion, two weeks for each arm

• Change in Interleukin-6

  Through study completion, two weeks for each arm

• Change in Interleukin-8

  Through study completion, two weeks for each arm

• Change in Interleukin-17

  Through study completion, two weeks for each arm

• Change in Tumor necrosis factor-alpha

  Through study completion, two weeks for each arm

Study Arms (2)

Intervention

EXPERIMENTAL

500 mg cherry supplement

Dietary Supplement: Montmorency cherry supplement

Control

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Control

Interventions

Montmorency cherry supplement DIETARY_SUPPLEMENT

Montmorency cherry supplement

Intervention

Control DIETARY_SUPPLEMENT

Placebo

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• unwilling or unable to stop the use of sleep medication
• unable to attend laboratory visits on the East Lansing, Michigan campus

Sponsors & Collaborators

• Michigan State University: lead
• Cherry Marketing Institute: collaborator

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Inflammation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 26, 2023
• Study Start: February 18, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)