Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

NCT ID: NCT05614947

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2025-07-25

Brief Summary

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tart cherry

two capsules daily for 60 days

Group Type: EXPERIMENTAL

Powdered tart cherry

Intervention Type: DIETARY_SUPPLEMENT

500 mg freeze-dried tart cherry per capsule

placebo

two capsules daily for 60 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

500 mg colored cornstarch per capsule

Interventions

Powdered tart cherry

500 mg freeze-dried tart cherry per capsule

Intervention Type: DIETARY_SUPPLEMENT

Placebo

500 mg colored cornstarch per capsule

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio University

OTHER

Sponsor Role: lead

Responsible Party

Angela Hillman

Assistant Professor of Exercise Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ohio University Exercise Physiology Lab

Athens, Ohio, United States

Countries

United States

Other Identifiers

20-F-16

Identifier Type: -

Identifier Source: org_study_id