Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614947
• Other study ID #: 20-F-16
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Powdered tart cherry
500 mg freeze-dried tart cherry per capsule
• Placebo
500 mg colored cornstarch per capsule

Locations

Country	Name	City	State
United States	Ohio University Exercise Physiology Lab	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

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