Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- HDL in mg/dl
Study Overview
Brief Summary
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.
Detailed Description
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:
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
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
Eligibility Criteria
- Ages
- 30 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •30-50 years of Type 2 Diabetic patients with past 5-15 years of diabetes Type 2
Exclusion Criteria
- •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
Arms & Interventions
Group 1
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.
Intervention: Raw fenugreek seed powder (Dietary Supplement)
Group 2
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.
Intervention: Roasted fenugreek seed powder (Dietary Supplement)
Outcomes
Primary Outcomes
HDL in mg/dl
Time Frame: 3 months
High Density Lipoprotein-Cholesterol will be assessed after the study in a private lab
Random Blood Sugar in mg/dl
Time Frame: Bimonthly till 3 months
Bimonthly Random blood sugar will be assessed via Glucometer
BMI will be checked in kg/^2
Time Frame: 3 months
BMI after study will be assessed as kg/m2
LDL in mg/dl
Time Frame: 3 months
Low Density Lipoprotein-Cholesterol will be tested after the intervention period
Cholesterol in mg/dl
Time Frame: 3 months
Cholesterol will be tested after the intervention period
Expected change in the level of HbA1c .
Time Frame: 3 months
HbA1c will be assessed after three months of trial through a blood sample
Fasting Blood Sugar in mg/dl
Time Frame: Bimonthly till 3 months
After every two weeks the fasting blood sugar will be assessed via Glucometer
Weight will be checked in kg
Time Frame: 3 months
weight machine will be used to assess weight in both groups after 3 months
Triglycerides in mg/dl
Time Frame: 3 months
Triglycerides will be tested after the intervention period
Secondary Outcomes
No secondary outcomes reported
Investigators
Sanaullah Iqbal
Associate Professor
University of Veterinary and Animal Sciences, Lahore - Pakistan