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临床试验/NCT06240273
NCT06240273尚未招募不适用

Assessment of Therapeutic Potential of Stigma Maydis (Cornsilk) on Metabolic Syndrome

University of Veterinary and Animal Sciences, Lahore - Pakistan0 个研究点目标入组 50 人开始时间: 2024年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
Blood pressure will be assessed before and after the trial.

研究概览

简要总结

Over the past two decades, there has been an increase in the number of people with nutrition related maladies due to changes in their dietary habits and lifestyle. Cardiovascular disease, type 2 diabetes, metabolic syndrome, obesity, and cancer have emerged as prominent contributors to both illness and death, particularly as the population continues to age. The mortality figures for cardiovascular disease and diabetes varied between 179.8 to 765.2 per 100,000 individuals, with the most elevated rates observed in poor nations. The occurrence of metabolic syndrome was markedly prevalent, spanning from 19% to 45%. The incidence of overweight and obesity (defined by a body mass index ≥25 kg/m2) has surged to concerning levels across many countries in the region, ranging from 25% to 82%, with a higher occurrence among women. Due to side effects of allopathic treatments and increase in nutrition knowledge people are more inclined to natural therapies. Subsequently, corn silk with nutraceutical properties may provide an effective alternative therapy to alleviate symptoms and decrease healthcare loss. Cornsilk, the often-overlooked byproduct of maize cultivation, is rich in bioactive compounds, including flavonoids, polysaccharides, and vitamins, cornsilk has shown promising effects in promoting health and wellness.

详细描述

Background:

Over the past two decades, there has been an increase in the number of people with nutrition related maladies due to changes in their dietary habits and lifestyle. Cardiovascular disease, type 2 diabetes, metabolic syndrome, obesity, and cancer have emerged as prominent contributors to both illness and death, particularly as the population continues to age. The mortality figures for cardiovascular disease and diabetes varied between 179.8 to 765.2 per 100,000 individuals, with the most elevated rates observed in poor nations. The occurrence of metabolic syndrome was markedly prevalent, spanning from 19% to 45%. The incidence of overweight and obesity (defined by a body mass index ≥25 kg/m2) has surged to concerning levels across many countries in the region, ranging from 25% to 82%, with a higher occurrence among women. Due to side effects of allopathic treatments and increase in nutrition knowledge people are more inclined to natural therapies. Subsequently, corn silk with nutraceutical properties may provide an effective alternative therapy to alleviate symptoms and decrease healthcare loss. Cornsilk, the often-overlooked byproduct of maize cultivation, is rich in bioactive compounds, including flavonoids, polysaccharides, and vitamins, cornsilk has shown promising effects in promoting health and wellness.

Hypothesis: Stigma maydis (corn silk) has a potential to manage metabolic syndrome.

Objective: To assess the therapeutic effect of Stigma maydis (corn silk) against metabolic syndrome.

Methodology: Cornsilk powder will be procured from a local market. The proximate analysis and total phenolic content of the product will be performed and then capsules of powder will be prepared to be consumed by the participants. A total of 40 subjects (20 in treatment group and 20 in control group) will be selected and capsules will be added to their diets (1000mg twice a day). After a trial of 45 days, the patients will be assessed. Assessment will include anthropometric measurements, blood pressure, lipid profile analysis and blood sugar levels which will be monitored before and after the trial and finally, the data collected will be analyzed by using SPSS 25 by paired sample t test. P value ≤ 0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

盲法说明

None (open-label) Participants Groups

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Waist Circumference of ≥40 inches in males and ≥35 inches for females
  • •Subjects having fasting total cholesterol level of ≥ 200 mg/dl or LDL cholesterol ≥ 130 mg/dl.
  • •Fasting Blood Glucose ≥110mg/dl.
  • •SBP ≥ 130/ ≥ 85 mmHg

排除标准

  • •Participants aged 55 or above • Participants who have less than two risk factors

研究组 & 干预措施

Metabolic Syndrome patients

Experimental

Cornsilk (Stigma maydis) is used for preventing symptoms of metabolic syndrome patients Dietary Intervention: Cornsilk Extract Dosage: 2g/day

干预措施: Corn silk powder (Dietary Supplement)

结局指标

主要结局

Blood pressure will be assessed before and after the trial.

时间窗: 45 days

The change in systolic and diastolic blood pressure will be measured after 45 days intervention of corn silk extract. The values will become close to optimized levels.

Lipid profile will be assessed before and after the trial.

时间窗: 45 days

The change in lipid profile, after 45 days intervention of corn silk extract, will be assessed. The value will be closed to optimized values.

waist circumference will be measured before and after the trial.

时间窗: 45 days

the change in weight will be measured after 45 days of corn silk extract intervention. The value will be close to normal ranges.

Fasting glucose level will be assessed before and after the trial.

时间窗: 45 days

The change in fasting glucose levels will be assessed after 45 days intervention of corn silk extract powder. The values will be become close to optimized levels

次要结局

未报告次要终点

研究者

发起方
University of Veterinary and Animal Sciences, Lahore - Pakistan
申办方类型
Other
责任方
Sponsor

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