Clinical trial NCT05614947: Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome
Official title: Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in baseline systolic and diastolic blood pressure
timeFrame: baseline, 60 days post supplmentation
measure: Change in fasting high-density lipoprotein (HDL) cholesterol
timeFrame: baseline, 30 days post supplementation, 60 days post supplmentation
measure: Change in fasting triglyceride levels
timeFrame: baseline, 30 days post supplementation, 60 days post supplmentation
measure: Change in fasting blood glucose level
timeFrame: baseline, 30 days post supplementation, 60 days post supplmentation
measure: Change in waist circumference
timeFrame: baseline, 60 days post supplmentation
measure: Change in body fat distribution
timeFrame: baseline, 60 days post supplmentation
measure: Change in erythrocyte sedimentation rate
timeFrame: baseline, 30 days post supplementation, 60 days post supplmentation
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University Exercise Physiology Lab
state: Ohio
Study officials:
References: