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Completed

NCT Number: NCT04467372

Tart Cherry Supplementation & Gut Microbiome and Inflammation

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.

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Key information

Conditions

Inflammation Glucose Regulation Pathologic Processes Pathological Conditions, Signs and Symptoms Sleep

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tart cherry juice concentrate

Dietary Supplement

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

Juice placebo

Dietary Supplement

Two 8oz bottles of placebo juice daily for 30 days

Freeze dried tart cherry powder

Dietary Supplement

Two freeze dried tart cherry powder capsules daily for 30 days

Capsule placebo

Dietary Supplement

Two placebo capsules daily for 30 days

Primary outcomes

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

    Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.

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

    Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.

  3. 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.

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

    Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.

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

    Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.

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

    Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.

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

    Time frame: daily for 30 days

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

    Time frame: daily for 30 days

  9. Changes in gut microbiome bacterial counts

    Time frame: baseline, 14 days, and 30 days post supplementation.

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jul 13, 2020
Registry last updated
Sep 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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