Clinical Trials Directory

Trials / Completed

CompletedNCT04467372

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.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Ohio University · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTTart cherry juice concentrateTwo 8oz bottles of tart cherry juice concentrate daily for 30 days
DIETARY_SUPPLEMENTJuice placeboTwo 8oz bottles of placebo juice daily for 30 days
DIETARY_SUPPLEMENTFreeze dried tart cherry powderTwo freeze dried tart cherry powder capsules daily for 30 days
DIETARY_SUPPLEMENTCapsule placeboTwo placebo capsules daily for 30 days

Timeline

Start date
2019-03-18
Primary completion
2019-10-16
Completion
2021-07-01
First posted
2020-07-13
Last updated
2021-09-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04467372. Inclusion in this directory is not an endorsement.