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临床试验/CTRI/2024/06/069562
CTRI/2024/06/069562尚未招募不适用

Effect of pumpkin seed on anthropometric, biochemical and genetic marker of Metabolic Syndrome

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 648 人开始时间: 2024年7月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
648
试验地点
1
主要终点
1.Manage reduction of Fasting blood glucose and Post prandial glucose

研究概览

简要总结

The metabolic syndrome is a cluster of risk factors that identifies a population with increased risk for developing type T2DM and cardiovascular disease (CVD). The prevalence of metabolic syndrome in urban population of India was 32%. The Adult Treatment Panel III (ATPIII) criteria of the National Cholesterol and Education Program (NCEP The diagnostic criteria for metabolic syndrome are the presence of any three of the following five components is diagnostic for the metabolic syndrome: Central obesity, elevated blood pressure, raised fasting glucose, raised levels of triglycerides and low levels of high-density lipoprotein cholesterol. Although, the most common treatment is medications but in recent time, use of nutritional methods and medicinal plants are also increasing and gaining importance due to their high margin of safety. However, some of them have been studied scientifically and pumpkin seed is one of them. Thus, the objective of the study was to assess the effect of pumpkin seeds on glycaemic profile, lipid profile, anthropometric measurements and adiponectin level and its gene expression in metabolic syndrome patients. The study patients will be recruited from OPD of Department of Medicine, with collaboration Department of Physiology, King Georges Medical University, Lucknow. Enrollment of patients will be done according to inclusion criteria. Then baseline assessments will be done of anthropometric measurements i.e., BMI, WHR, biochemical parameters like CBC, FBS, PPBS, HbA1c and TG, TC, LDL, HDL, IL-6 (Interleukin-6), Tumor necrosis factor- alpha (TNF-α), Adiponectin level and its Gene Expression and clinical parameters including BP and Heart rate. Then supplementation of 30 gm pumpkin seed per day i.e., 15 gm before half an hour of breakfast and 15 gm before half an hour of dinner will be given to the case group patients for 3 months and no intervention in the control group will be given. Compliance of daily consumption of pumpkin seeds would be monitored in the case group. All case group patients will be requested to return their supplement packaging every month. The pumpkin seeds will be provided to the patients every month for a duration of 3 months. The follow up assessment of the patients will be done after 3 months of pumpkin seed supplementation. The baseline and follow up assessments, data will be compiled, entered in Microsoft Excel spreadsheet for further data statistical analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Metabolic syndrome patients aged between 18-60 years
  • Metabolic Syndrome with three or more of the following five criteria is met: hyperglycemia, raised blood pressure, elevated triglyceride levels, low high-density lipoprotein cholesterol levels, and central obesity [NCEP (ATP III)].
  • Patient of either sex i.e., both male and female.
  • Patient willing to consent in writing.

排除标准

  • Patient not willing to participate in the study
  • Aged less than 18 and more than 60years
  • Pregnant, nursing, or planning for pregnancy
  • Active medical condition- a known allergy or intolerance
  • Patient having any medical or surgical illness requiring priority management
  • Patient with other endocrinal diseases
  • Patient with Frank hepatorenal complication
  • Patient with chronic illness, congenital disorder, neurological and psychiatric disorder.

结局指标

主要结局

1.Manage reduction of Fasting blood glucose and Post prandial glucose

时间窗: Glycaemic profile will be measured: | First is at Baseline (at the time of patient | enrollment) | Second is Follow-up (after 12 weeks {3 | months} of patient enrollment)

2. Decrease HbA1c

时间窗: Glycaemic profile will be measured: | First is at Baseline (at the time of patient | enrollment) | Second is Follow-up (after 12 weeks {3 | months} of patient enrollment)

次要结局

  • 3. Decrease Triglycerides, low-density(lipoproteins Cholesterol, Total)

研究者

申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Dileep Kumar Verma

King Georges Medical University

研究点 (1)

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