Tart Cherry Supplementation & Gut Microbiome and Inflammation

Not Applicable

Completed

• Conditions: Inflammation; Sleep; Glucose Regulation
• Interventions: Dietary Supplement: Tart cherry juice concentrate; Dietary Supplement: Capsule placebo; Dietary Supplement: Freeze dried tart cherry powder; Dietary Supplement: Juice placebo

• Registration Number: NCT04467372
• Lead Sponsor: Ohio University

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-18
• Primary Completion: 2019-10-16
• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-08
• Study First Posted: 2020-07-13
• Study Completion: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tart cherry juice concentrate	Tart cherry juice concentrate	tart cherry juice
Capsule placebo	Capsule placebo	maltodextrin
Freeze dried tart cherry powder	Freeze dried tart cherry powder	tart cherry capsules
Juice placebo	Juice placebo	kool-aid

Primary Outcome Measures

Name	Time	Method
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 inflammation measured via erythrocyte sedimentation rate (mm/hour)	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.
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 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.

Trial Locations

Locations (1)

Ohio University Exercise Physiology Lab; 🇺🇸 Athens, Ohio, United States