Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

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:

      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

      Phase 1: Processing of fenugreek Fenugreek will be brought form the local market and will be
      cleaned for the stones and straws. Fenugreek seeds will be roasted in oven at approximately
      130 ± 5 °C for 7 minutes with stirring at regular intervals with laddle so that it will
      properly and uniformly roasted and it will turn to slight brownish colour along with peculiar
      aroma. Raw and Roasted fenugreek seeds will be grounded in grinder to get uniform sized
      flour. Flours will be collected and stored in air tight food grade containers separately for
      further use at ambient temperature.

      Phase 2: Assessment of diabetic patients regards to inclusion and exclusion criteria and
      groups assignment along with fenugreek sachets

      Subjects:

      For the study the diabetic patients will be gathered in the diabetic camp at Lahore where
      their anthropometric and blood sample collection will be done. The participants will be
      divided in to two groups Group 1 and group 2 with equal participants of 15 in each group.
      Total 30 patients of Type 2 Diabetes will be selected for this clinical trial .The inclusion
      criteria include age ranging from 30-50 years old male and female type 2 diabetic patients
      from Lahore with informed consent and Patients with Diabetes diagnosed from past 5- 15 years.
      The exclusion criteria consist of: Anyone suffering from any other chronic disease like
      Cardiac, Pulmonary and Chronic Renal Disease and patients other than inclusion criteria, any
      diabetic patients on Insulin therapy and Pregnant and Breastfeeding women. Any one suffering
      from chickpeas, peanut or coriander allergy. Height, weight and BMI of all patients will be
      checked as anthropometric measures. Patients BMI will be classified according to WHO
      criteria.

      Whereas BMI =Weight in kg/Height in meter squares. Random, fasting blood sugars will be
      tested along with HbA1c and Lipid profile. The participants will be divided in to two groups
      one with Raw fenugreek and second with Roasted one. The duration of the study will be 3
      months.

      Experimental design:

      Group 1 will be given Raw Fenugreek in Ziploc sachets of 7.5 grams (2 sachets for a day
      equals to 15 grams) for every 2 weeks, ultimately for period of 3 months. Bimonthly their
      Fasting and Random Blood sugar will be checked also. Participants will be told to take 1
      sachet before breakfast and one before dinner. Similarly Group 2 will be given the Roasted
      fenugreek in the same manner as that of group 1.The participants will be allowed to take
      their regular oral medications like metformin for diabetes. There will be a gap of 1-2 hours
      between oral medications (oral hypoglycemic agents) and fenugreek intake as its fiber becomes
      mucilaginous and can interfere with the drug activity.

      Biochemical testing:

      Anthropometric measurements such as height weight and BMI will be checked at baseline, and
      after three months. Besides the anthropometry, the study participant's Fasting and Random
      Blood glucose levels will be checked before, after every two weeks and after completion of
      the study. In addition after every 2 weeks through Glucometer by using finger prick method.
      Before, and at the end of the study HbA1c will be checked also. Patients Blood Lipid Profile
      will also be checked before and after the study.

      Phase 3: Assessment of biochemical tests and anthropometric measurements at the end of the
      study At the end of the study, HbA1c along with fasting and Random Blood Sugars will be
      tested so that effectiveness of both groups to their baselines can be compared after the
      study. Lipid profile will also be monitored and compared to the base lines. Their height,
      weight and BMI will also be monitored at the end of the study and will be compared to the
      baselines.

      Statistical analysis:

      Statistical Package for Social Science software (version 22) will be used for the analysis of
      data. Independent t test will be applied to check the differences between group 1 and group 2
      at baseline. Paired t test will be used to check the differences between baselines and final
      results after treatment within a group. One way ANOVA will also be used.The level of
      significance will be <0.05
    

Intervention name(s): Raw fenugreek seed powder; Roasted fenugreek seed powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): It will be given to group 1; It will be given to group 2
Intervention MeSH terms: Fenugreek seed meal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two groups, Group 1 will be given raw fenugreek and group 2 will be given roasted fenugreek. Results will be compared to baselines.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fenugreek; Diabetes; HbA1c; Hyperglycemia; Blood glucose; Raw versus Roasted fenugreek; Type 2 Diabetes; Lipid profile; Cholesterol; Triglycerides; HDL; LDL