Tart Cherry Supplementation & Gut Microbiome and Inflammation

NCT04467372 | Completed

• 1 other identifier: 18-F-13
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Glucose Regulation; Sleep

Outcome Measures

Primary Outcomes (9)

• Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)

  baseline, 7 days, 14 days, and 30 days post supplementation.

• Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)

  baseline, 7 days, 14 days, and 30 days post supplementation.

• 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.

• Changes in glucose regulation assessed via plasma glucose (mg/dL)

  baseline, 7 days, 14 days, and 30 days post supplementation.

• Changes in glucose regulation assessed via insulin (mIU/L)

  baseline, 7 days, 14 days, and 30 days post supplementation.

• Changes in glucose regulation assessed via glycated albumin (%).

  baseline, 7 days, 14 days, and 30 days post supplementation.

• Changes in sleep quantity (hours and minutes) assessed via daily survey.

  daily for 30 days

• Changes in sleep quality measured via 100mm visual analogue scale.

  daily for 30 days

• Changes in gut microbiome bacterial counts

  baseline, 14 days, and 30 days post supplementation.

Study Arms (4)

Tart cherry juice concentrate

EXPERIMENTAL

tart cherry juice

Dietary Supplement: Tart cherry juice concentrate

Freeze dried tart cherry powder

EXPERIMENTAL

tart cherry capsules

Dietary Supplement: Freeze dried tart cherry powder

Juice placebo

EXPERIMENTAL

kool-aid

Dietary Supplement: Juice placebo

Capsule placebo

EXPERIMENTAL

maltodextrin

Dietary Supplement: Capsule placebo

Interventions

Tart cherry juice concentrate DIETARY_SUPPLEMENT

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

Tart cherry juice concentrate

Juice placebo DIETARY_SUPPLEMENT

Two 8oz bottles of placebo juice daily for 30 days

Juice placebo

Freeze dried tart cherry powder DIETARY_SUPPLEMENT

Two freeze dried tart cherry powder capsules daily for 30 days

Freeze dried tart cherry powder

Capsule placebo DIETARY_SUPPLEMENT

Two placebo capsules daily for 30 days

Capsule placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio University: lead

Study Sites (1)

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

Location

Related Publications (1)

• 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.

  PMID: 34604282 DERIVED

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 13, 2020
• Study Start: March 18, 2019
• Primary Completion: October 16, 2019
• Study Completion: July 1, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)