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Polyphenol Supplement
Tart Cherry Supplement for Metabolic Syndrome
N/A
Recruiting
Research Sponsored by Ohio University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
Major organ system impairment (heart failure, renal failure, severe impairment of respiratory function)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial aims to test the effects of tart cherry supplements on MetSyn, a growing health concern linked to cardiovascular diseases & type II diabetes, with treatment including exercise & weight loss.
Who is the study for?
This trial is for adults aged 25-60 with metabolic syndrome, characterized by a large waistline, high blood pressure or medication use for it, abnormal cholesterol levels, and elevated fasting blood sugar. Participants should not have inflammatory conditions, be on anti-inflammatory meds or steroids recently, have major organ failure, smoke currently or quit within the last year.
What is being tested?
The study tests if powdered tart cherry supplements can improve metabolic syndrome over 60 days. It compares the effects of these supplements to a placebo (a substance with no therapeutic effect) on body mass, waist size, blood pressure, lipid levels and glucose control in participants.
What are the potential side effects?
While specific side effects are not listed for powdered tart cherry supplements in this context; generally such natural products may cause digestive discomfort or allergic reactions in some individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with metabolic syndrome or meet its criteria.
Select...
I am between 25 and 60 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have major heart, kidney, or severe lung problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: tart cherryExperimental Treatment1 Intervention
two capsules daily for 60 days
Group II: placeboPlacebo Group1 Intervention
two capsules daily for 60 days
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Who is running the clinical trial?
Ohio UniversityLead Sponsor
71 Previous Clinical Trials
37,181 Total Patients Enrolled
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Research Study Groups:
This trial has the following groups:- Group 1: tart cherry
- Group 2: placebo
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