An interventional study of Tart cherry juice concentrate and Juice placebo in Inflammation, Glucose Regulation and Sleep, sponsored by Ohio University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by Ohio University · Not applicable, Interventional, and Basic science
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.
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.
3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.
This study's enrollment of 70 is above the median of 50 across 2,437 interventional studies indexed under Inflammation.
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Exclusion Criteria:
tart cherry juice
Dietary Supplement: Tart cherry juice concentrate
tart cherry capsules
Dietary Supplement: Freeze dried tart cherry powder
kool-aid
Dietary Supplement: Juice placebo
maltodextrin
Dietary Supplement: Capsule placebo
Two 8oz bottles of tart cherry juice concentrate daily for 30 days
Two 8oz bottles of placebo juice daily for 30 days
Two freeze dried tart cherry powder capsules daily for 30 days
Two placebo capsules daily for 30 days
Changes in inflammation measured via tumor necrosis factor alpha (pg/mL)
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in inflammation measured via erythrocyte sedimentation rate (mm/hour)
Time frame: 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).
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via plasma glucose (mg/dL)
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via insulin (mIU/L)
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in glucose regulation assessed via glycated albumin (%).
Time frame: baseline, 7 days, 14 days, and 30 days post supplementation.
Changes in sleep quantity (hours and minutes) assessed via daily survey.
Time frame: daily for 30 days
Changes in sleep quality measured via 100mm visual analogue scale.
Time frame: daily for 30 days
Changes in gut microbiome bacterial counts
Time frame: baseline, 14 days, and 30 days post supplementation.
Plan to share: No — Available by request
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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