Tart Cherry Supplementation & Gut Microbiome and Inflammation

The Effects Supplementation of Tart Cherry or Placebo on the Gut Microbiome, Inflammation, Oxidative Stress, and Health-related Outcomes.

There has been a rapid increase in researching the use of tart cherry supplements in the past 5 years, particularly for inflammatory conditions. Many formulations of cherry supplements exist, however there has been no comparison between these different types. This is particularly important in the realm of inflammation research because sugar is known to increase the inflammatory response. The pill form of cherry supplementation has no added sugar and is naturally low in sugar (< 1g) while the juice form is higher from added sugar. Recent work indicates tart cherry consumption can change gut microbiota, which may modify inflammation. The purpose of this study is to look at the effects of taking a cherry supplement, either in capsule or juice form, on the gut microbiome, inflammation, and health-related variables such as blood pressure, glucose regulation and sleep quality.

Study Overview

• Status: Completed
• Conditions: Inflammation; Sleep; Glucose Regulation
• Intervention / Treatment: Dietary supplement: Tart cherry juice concentrate; Dietary supplement: Freeze dried tart cherry powder; Dietary supplement: Juice placebo; Dietary supplement: Capsule placebo

Detailed Description

Participants will consume a tart cherry or placebo product for 30 days and attend 5 visits in the Exercise Physiology Lab at Ohio University over the 30 day period. They will self-collect a stool sample at baseline, 14 days and 30 days after supplementation. Blood samples will be taken at baseline, 7 days, 14 days, and 30 days after supplementation. Throughout the study participates will rate symptoms (stomach, head, etc.), pain and sleep quality using an online survey for which the link will be emailed. Participants will maintain normal diet and exercise routine and to track these for the duration of the study.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University Exercise Physiology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-55 years old
• participate in 150 minutes of exercise per week
• non-smoker
• have no known allergy to cherries or cherry juice
• are not taking food supplements (turmeric/curcumin, cherry products, greens, etc.). -You must have access to the internet and be willing to record your food intake, physical activity and sleep quality/duration during the study.

Exclusion Criteria:

• not 18-55 years old.
• have quit smoking less than one year ago.
• have been diagnosed with a metabolic disorder such as diabetes, thyroid disorder, or high cholesterol.
• are currently being treated for arthritis or an inflammatory condition, such as arthritis, gout, lupus or Sjogren's syndrome.
• are currently being treated for cardiovascular disease, high blood pressure, fibromyalgia, or irritable bowel syndrome.
• are pregnant.
• regularly consume cherries or are allergic to cherries.
• currently use anti-inflammatory medications.
• have used corticosteroids in the last two months.
• are not willing to follow a low polyphenol diet.
• are not willing to have blood drawn on 4 occasions.
• are not willing to provide a stool sample on 3 occasions.
• do not have access to the internet.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tart cherry juice concentrate; tart cherry juice	Dietary supplement: Tart cherry juice concentrate; Two 8oz bottles of tart cherry juice concentrate daily for 30 days
Experimental: Freeze dried tart cherry powder; tart cherry capsules	Dietary supplement: Freeze dried tart cherry powder; Two freeze dried tart cherry powder capsules daily for 30 days
Experimental: Juice placebo; kool-aid	Dietary supplement: Juice placebo; Two 8oz bottles of placebo juice daily for 30 days
Experimental: Capsule placebo; maltodextrin	Dietary supplement: Capsule placebo; Two placebo capsules daily for 30 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)	baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)	baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in inflammation measured via c-reactive protein (mg/L) and uric acid (mg/dL).	baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via plasma glucose (mg/dL)	baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via insulin (mIU/L)	baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via glycated albumin (%).	baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in sleep quantity (hours and minutes) assessed via daily survey.	daily for 30 days
Changes in sleep quality measured via 100mm visual analogue scale.	daily for 30 days
Changes in gut microbiome bacterial counts	baseline, 14 days, and 30 days post supplementation.

Collaborators and Investigators

• Sponsor: Ohio University

Publications and helpful links

General Publications

• Hillman AR, Chrismas BCR. Thirty Days of Montmorency Tart Cherry Supplementation Has No Effect on Gut Microbiome Composition, Inflammation, or Glycemic Control in Healthy Adults. Front Nutr. 2021 Sep 16;8:733057. doi: 10.3389/fnut.2021.733057. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2019
• Primary Completion (Actual): October 16, 2019
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 9, 2021
• Last Update Submitted That Met QC Criteria: September 8, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: 18-F-13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Available by request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No