Clinical trial NCT05550870: Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients
Official title: Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Fenugreek
Diabetes
HbA1c
Hyperglycemia
Blood glucose
Raw versus Roasted fenugreek
Type 2 Diabetes
Lipid profile
Cholesterol
Triglycerides
HDL
LDL
Lead sponsor: University of Veterinary and Animal Sciences, Lahore - Pakistan
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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:

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

Eligibility criteria: 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

Primary outcomes:
measure: Expected change in the level of HbA1c .
timeFrame: 3 months
measure: Weight will be checked in kg
timeFrame: 3 months
measure: BMI will be checked in kg/^2
timeFrame: 3 months
measure: Fasting Blood Sugar in mg/dl
timeFrame: Bimonthly till 3 months
measure: Random Blood Sugar in mg/dl
timeFrame: Bimonthly till 3 months
measure: HDL in mg/dl
timeFrame: 3 months
measure: LDL in mg/dl
timeFrame: 3 months
measure: Triglycerides in mg/dl
timeFrame: 3 months
measure: Cholesterol in mg/dl
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: University of Veterinary and Animal Sciences, Paksitan
state: Punjab
Study officials:
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