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临床试验/NCT05550870
NCT05550870已完成不适用

Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients

University of Veterinary and Animal Sciences, Lahore - Pakistan1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2022年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
HDL in mg/dl

研究概览

简要总结

Diabetes is a metabolic disorder that causes high glucose levels in the blood and leads to various complications with time such as Retinopathy, neuropathy, and nephropathy, and puts a lot of burden on the health of a person as well as economy of country. Fenugreek is being used for decades in the treatment of various diseases and disorders including diabetes. With the advancement of medical nutrition therapy and processing techniques, it is being used in roasted or cooked form. But previous studies indicate that processing like roasting decrease the fiber content of fenugreek seed and this fiber mainly galactomannan is responsible for reducing hyperglycemia. Another study tells us that in raw form the glycemic index is lowered as compared to roasted or other forms.According to another study the antioxidant activity is increased in roasted form as compared form. So in this study, a clinical trial will be done on two groups of 15 type 2 diabetic patients each that have neither other complications nor on insulin therapy. These total 30 patients Height, Weight, BMI, Fasting and Random Blood sugars, HbA1c, and lipid profile will be checked before the study and after 3 months of a clinical trial. Group 1 will be given Raw fenugreek seed powder and group 2 will be given Roasted fenugreek seed powder 7.5 grams twice a day.The study will be single blinded.

详细描述

Diabetes mellitus is a metabolic disorder that is marked by high glucose levels in the blood because of insulin resistance or inability of the pancreas to make enough insulin for proper working of carbohydrate metabolism. It is easily obvious from the literature that its prevalence is increasing day by day and in future it seems to rise more. Its complications lead to more problematic situation for the health of diabetic person itself and the economy with each day. Its management includes diet, physical activity and medications. As a dietary component different spices are being used for years like cinnamon and fenugreek. Many people use fenugreek in various forms like its incorporation in chapatti, Indian dish Dosa and others but the form of fenugreek is still un known based on the effectiveness that either it will be more beneficial in cooked form like roasting or in raw form for reducing hyperglycemia, because many people take it in roasted form as it decreases its bitterness. As fenugreek is cheap it is of major concern of many diabetic patients for diabetes management.

This study is aimed to determine the effect of Raw versus Roasted Fenugreek seed powder in reducing the blood glucose levels in Type 2 Diabetic patients which will be evidenced by Fasting Blood Glucose, Random Blood Glucose and HbA1c

OBJECTIVE of the study is:

  1. To explore the potential of Raw and Roasted fenugreek against biomarkers of Type 2 Diabetes in Diabetic Patients.

The methodology of the study comprises of three different phases. Phase 1: Processing of fenugreek Phase 2: Assessment of diabetic patients regards to inclusion and exclusion criteria and groups assignment along with fenugreek sachets Phase 3: Assessment of biochemical tests and anthropometric measurements at the end of the study

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
Single (Participant)

盲法说明

It is a single-blind clinical trial, in which patients know that fenugreek is being given to them but which form either raw or roasted is unknown to them

入排标准

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

入选标准

  • •30-50 years of Type 2 Diabetic patients with past 5-15 years of diabetes Type 2

排除标准

  • •Any patient on insulin therapy
  • •Patients with other chronic diseases like Cardiac, Renal, or Pulmonary diseases.
  • •Pregnant and Lactating mothers
  • •Anyone with peanut or coriander allergy or Allergy to Fabeace Family

研究组 & 干预措施

Group 1

Experimental

Group 1 will be given Raw Fenugreek seed powder. The dose will be 7.5grams two times a day i.e, before breakfast and before dinner for the period of three months.

干预措施: Raw fenugreek seed powder (Dietary Supplement)

Group 2

Experimental

Group 2 will be given Roasted Fenugreek seed powder, 7.5 grams twice a day before breakfast and dinner for the period of three months.Total number of arms will be 2.

干预措施: Roasted fenugreek seed powder (Dietary Supplement)

结局指标

主要结局

HDL in mg/dl

时间窗: 3 months

High Density Lipoprotein-Cholesterol will be assessed after the study in a private lab

Random Blood Sugar in mg/dl

时间窗: Bimonthly till 3 months

Bimonthly Random blood sugar will be assessed via Glucometer

BMI will be checked in kg/^2

时间窗: 3 months

BMI after study will be assessed as kg/m2

LDL in mg/dl

时间窗: 3 months

Low Density Lipoprotein-Cholesterol will be tested after the intervention period

Cholesterol in mg/dl

时间窗: 3 months

Cholesterol will be tested after the intervention period

Expected change in the level of HbA1c .

时间窗: 3 months

HbA1c will be assessed after three months of trial through a blood sample

Fasting Blood Sugar in mg/dl

时间窗: Bimonthly till 3 months

After every two weeks the fasting blood sugar will be assessed via Glucometer

Weight will be checked in kg

时间窗: 3 months

weight machine will be used to assess weight in both groups after 3 months

Triglycerides in mg/dl

时间窗: 3 months

Triglycerides will be tested after the intervention period

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
Principal Investigator
主要研究者

Sanaullah Iqbal

Associate Professor

University of Veterinary and Animal Sciences, Lahore - Pakistan

研究点 (1)

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