search
Back to results

Tart Cherry Supplementation & Gut Microbiome and Inflammation

Primary Purpose

Inflammation, Glucose Regulation, Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tart cherry juice concentrate
Juice placebo
Freeze dried tart cherry powder
Capsule placebo
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ohio University Exercise Physiology Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Tart cherry juice concentrate

Freeze dried tart cherry powder

Juice placebo

Capsule placebo

Arm Description

tart cherry juice

tart cherry capsules

kool-aid

maltodextrin

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 30, 2020
Last Updated
September 8, 2021
Sponsor
Ohio University
search

1. Study Identification

Unique Protocol Identification Number
NCT04467372
Brief Title
Tart Cherry Supplementation & Gut Microbiome and Inflammation
Official Title
The Effects Supplementation of Tart Cherry or Placebo on the Gut Microbiome, Inflammation, Oxidative Stress, and Health-related Outcomes.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 18, 2019 (Actual)
Primary Completion Date
October 16, 2019 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Glucose Regulation, Sleep

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tart cherry juice concentrate
Arm Type
Experimental
Arm Description
tart cherry juice
Arm Title
Freeze dried tart cherry powder
Arm Type
Experimental
Arm Description
tart cherry capsules
Arm Title
Juice placebo
Arm Type
Experimental
Arm Description
kool-aid
Arm Title
Capsule placebo
Arm Type
Experimental
Arm Description
maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Tart cherry juice concentrate
Intervention Description
Two 8oz bottles of tart cherry juice concentrate daily for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Juice placebo
Intervention Description
Two 8oz bottles of placebo juice daily for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Freeze dried tart cherry powder
Intervention Description
Two freeze dried tart cherry powder capsules daily for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Capsule placebo
Intervention Description
Two placebo capsules daily for 30 days
Primary Outcome Measure Information:
Title
Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)
Time Frame
baseline, 7 days, 14 days, and 30 days post supplementation.
Title
Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)
Time Frame
baseline, 7 days, 14 days, and 30 days post supplementation.
Title
Changes in inflammation measured via c-reactive protein (mg/L) and uric acid (mg/dL).
Time Frame
baseline, 7 days, 14 days, and 30 days post supplementation.
Title
Changes in glucose regulation assessed via plasma glucose (mg/dL)
Time Frame
baseline, 7 days, 14 days, and 30 days post supplementation.
Title
Changes in glucose regulation assessed via insulin (mIU/L)
Time Frame
baseline, 7 days, 14 days, and 30 days post supplementation.
Title
Changes in glucose regulation assessed via glycated albumin (%).
Time Frame
baseline, 7 days, 14 days, and 30 days post supplementation.
Title
Changes in sleep quantity (hours and minutes) assessed via daily survey.
Time Frame
daily for 30 days
Title
Changes in sleep quality measured via 100mm visual analogue scale.
Time Frame
daily for 30 days
Title
Changes in gut microbiome bacterial counts
Time Frame
baseline, 14 days, and 30 days post supplementation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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. 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.
Facility Information:
Facility Name
Ohio University Exercise Physiology Lab
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Available by request
Citations:
PubMed Identifier
34604282
Citation
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.
Results Reference
derived

Learn more about this trial

Tart Cherry Supplementation & Gut Microbiome and Inflammation

We'll reach out to this number within 24 hrs