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OpenTrials
Completed

NCT Number: NCT05614947

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University Exercise Physiology Lab

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Powdered tart cherry

Dietary Supplement

500 mg freeze-dried tart cherry per capsule

Placebo

Dietary Supplement

500 mg colored cornstarch per capsule

Primary outcomes

  1. Change in baseline systolic and diastolic blood pressure

    Time frame: baseline, 60 days post supplmentation

  2. Change in fasting high-density lipoprotein (HDL) cholesterol

    Time frame: baseline, 30 days post supplementation, 60 days post supplmentation

  3. Change in fasting triglyceride levels

    Time frame: baseline, 30 days post supplementation, 60 days post supplmentation

  4. Change in fasting blood glucose level

    Time frame: baseline, 30 days post supplementation, 60 days post supplmentation

  5. Change in waist circumference

    Time frame: baseline, 60 days post supplmentation

  6. Change in body fat distribution

    Time frame: baseline, 60 days post supplmentation

  7. Change in erythrocyte sedimentation rate

    Time frame: baseline, 30 days post supplementation, 60 days post supplmentation

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 14, 2022
Registry last updated
Jul 30, 2025

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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