Tart Cherry Supplementation & Gut Microbiome and Inflammation

NCT ID: NCT04467372

Last Updated: 2021-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-18

Study Completion Date

2021-07-01

Brief Summary

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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

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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

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Inflammation Glucose Regulation Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Tart cherry juice concentrate

tart cherry juice

Group Type EXPERIMENTAL

Tart cherry juice concentrate

Intervention Type DIETARY_SUPPLEMENT

Two 8oz bottles of tart cherry juice concentrate daily for 30 days

Freeze dried tart cherry powder

tart cherry capsules

Group Type EXPERIMENTAL

Freeze dried tart cherry powder

Intervention Type DIETARY_SUPPLEMENT

Two freeze dried tart cherry powder capsules daily for 30 days

Juice placebo

kool-aid

Group Type EXPERIMENTAL

Juice placebo

Intervention Type DIETARY_SUPPLEMENT

Two 8oz bottles of placebo juice daily for 30 days

Capsule placebo

maltodextrin

Group Type EXPERIMENTAL

Capsule placebo

Intervention Type DIETARY_SUPPLEMENT

Two placebo capsules daily for 30 days

Interventions

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Tart cherry juice concentrate

Two 8oz bottles of tart cherry juice concentrate daily for 30 days

Intervention Type DIETARY_SUPPLEMENT

Juice placebo

Two 8oz bottles of placebo juice daily for 30 days

Intervention Type DIETARY_SUPPLEMENT

Freeze dried tart cherry powder

Two freeze dried tart cherry powder capsules daily for 30 days

Intervention Type DIETARY_SUPPLEMENT

Capsule placebo

Two placebo capsules daily for 30 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio University

OTHER

Sponsor Role lead

Responsible Party

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Angela Hillman

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ohio University Exercise Physiology Lab

Athens, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34604282 (View on PubMed)

Other Identifiers

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18-F-13

Identifier Type: -

Identifier Source: org_study_id

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