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

Ohio University1 site in 1 country70 target enrollmentMarch 18, 2019

ConditionsInflammation Glucose Regulation Sleep

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammation
Sponsor: Ohio University
Enrollment: 70
Locations: 1
Primary Endpoint: Changes in glucose regulation assessed via glycated albumin (%).
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 18, 2019

End Date

July 1, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ohio University

Responsible Party

Principal Investigator

Angela Hillman

Assistant Professor

Ohio University

Eligibility Criteria

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.