Tart Cherry Supplementation & Gut Microbiome and Inflammation

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04467372
• Other study ID #: 18-F-13
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2021
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 1, 2021
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Regulation
• Inflammation
• Sleep

Intervention

Dietary Supplement:
• Tart cherry juice concentrate
Two 8oz bottles of tart cherry juice concentrate daily for 30 days
• Juice placebo
Two 8oz bottles of placebo juice daily for 30 days
• Freeze dried tart cherry powder
Two freeze dried tart cherry powder capsules daily for 30 days
• Capsule placebo
Two placebo capsules daily for 30 days

Locations

Country	Name	City	State
United States	Ohio University Exercise Physiology Lab	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

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