Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Metabolic syndrome (MetSyn) is a growing health concern, with up to 25% of the worlds population having the syndrome. MetSyn is a primary risk factor for cardiovascular disease and type II diabetes development, and is independently associated with all-cause mortality, making it an important disease target. The primary treatment for MetSyn is exercise and weight loss, along with medically necessary treatment. Exercise, along with dietary changes such as increased fiber and polyphenol intake can positively impact many of the metabolic abnormalities seen with MetSyn. For example, polyphenols have been shown to decrease lipid concentration and improved glucose clearance as well as decreased oxidative stress and inflammation. Powdered tart cherry capsules, which contain the skin of the fruit, provides polysaccharides (fiber) that would likely act as a substrate for gut bacteria degradation, providing energy substrates and barrier integrity to the colonocytes and increasing the bioavailability of the polyphenols to other cells in the body. However there have been no long-term investigations into the use of powdered tart cherry supplements in MetSyn, therefore we aim to determine if 60 days tart cherry supplementation modify criteria for MetSyn in currently diagnosed individuals including body mass, waist circumference, blood pressure, blood lipid levels and blood glucose control.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Powdered tart cherry; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University Exercise Physiology Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have been diagnosed with metabolic syndrome by a physician or meet the diagnostic criteria: Waist circumference greater than 40 inches (men) or greater than 35 inches (women), High blood pressure (greater than 130/80) or taking medication for high blood pressure, High triglycerides (greater than 150 mg/dL) or low HDL (less than 40 for men, less than 50 for women), High fasting blood glucose (100-126 mg/dL) or diagnosed as pre-diabetic
• Age 25-60

Exclusion Criteria:

• currently taking medication for glucose or lipid control, such as metformin and/or statin
• currently using anti-inflammatory medications & have not used corticosteroids in the last two months
• diagnosed with or currently being treated for an inflammatory condition
• major organ system impairment (heart failure, renal failure, severe impairment of respiratory function)
• currently a smoker or quit less than 12 months ago

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tart cherry; two capsules daily for 60 days	Dietary supplement: Powdered tart cherry; 500 mg freeze-dried tart cherry per capsule
Placebo Comparator: placebo; two capsules daily for 60 days	Dietary supplement: Placebo; 500 mg colored cornstarch per capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in baseline systolic and diastolic blood pressure	baseline, 60 days post supplmentation
Change in fasting high-density lipoprotein (HDL) cholesterol	baseline, 30 days post supplementation, 60 days post supplmentation
Change in fasting triglyceride levels	baseline, 30 days post supplementation, 60 days post supplmentation
Change in fasting blood glucose level	baseline, 30 days post supplementation, 60 days post supplmentation
Change in waist circumference	baseline, 60 days post supplmentation
Change in body fat distribution	baseline, 60 days post supplmentation
Change in erythrocyte sedimentation rate	baseline, 30 days post supplementation, 60 days post supplmentation

Collaborators and Investigators

• Sponsor: Ohio University

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): July 25, 2025

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Disease; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 20-F-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No