Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Powdered tart cherry
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tart cherry<br>two capsules daily for 60 days | Dietary Supplement: Powdered tart cherry<br>* 500 mg freeze-dried tart cherry per capsule<br>|
| Placebo Comparator: placebo<br>two capsules daily for 60 days | Dietary Supplement: Placebo<br>* 500 mg colored cornstarch per capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |