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临床试验/NCT05614947
NCT05614947已完成不适用

Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Ohio University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年4月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Change in fasting triglyceride levels

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in fasting triglyceride levels

时间窗: baseline, 30 days post supplementation, 60 days post supplmentation

Change in baseline systolic and diastolic blood pressure

时间窗: baseline, 60 days post supplmentation

Change in waist circumference

时间窗: baseline, 60 days post supplmentation

Change in erythrocyte sedimentation rate

时间窗: baseline, 30 days post supplementation, 60 days post supplmentation

Change in fasting high-density lipoprotein (HDL) cholesterol

时间窗: baseline, 30 days post supplementation, 60 days post supplmentation

Change in body fat distribution

时间窗: baseline, 60 days post supplmentation

Change in fasting blood glucose level

时间窗: baseline, 30 days post supplementation, 60 days post supplmentation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Hillman

Assistant Professor of Exercise Physiology

Ohio University

研究点 (2)

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