- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05550870
Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan
- University of Veterinary and Animal Sciences, Paksitan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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It will be given to group 1
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Experimental: 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.
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It will be given to group 2
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expected change in the level of HbA1c .
Time Frame: 3 months
|
HbA1c will be assessed after three months of trial through a blood sample
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3 months
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Weight will be checked in kg
Time Frame: 3 months
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weight machine will be used to assess weight in both groups after 3 months
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3 months
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BMI will be checked in kg/^2
Time Frame: 3 months
|
BMI after study will be assessed as kg/m2
|
3 months
|
Fasting Blood Sugar in mg/dl
Time Frame: Bimonthly till 3 months
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After every two weeks the fasting blood sugar will be assessed via Glucometer
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Bimonthly till 3 months
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Random Blood Sugar in mg/dl
Time Frame: Bimonthly till 3 months
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Bimonthly Random blood sugar will be assessed via Glucometer
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Bimonthly till 3 months
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HDL in mg/dl
Time Frame: 3 months
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High Density Lipoprotein-Cholesterol will be assessed after the study in a private lab
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3 months
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LDL in mg/dl
Time Frame: 3 months
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Low Density Lipoprotein-Cholesterol will be tested after the intervention period
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3 months
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Triglycerides in mg/dl
Time Frame: 3 months
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Triglycerides will be tested after the intervention period
|
3 months
|
Cholesterol in mg/dl
Time Frame: 3 months
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Cholesterol will be tested after the intervention period
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3 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010 Jan;33 Suppl 1(Suppl 1):S62-9. doi: 10.2337/dc10-S062. No abstract available. Erratum In: Diabetes Care. 2010 Apr;33(4):e57.
- Kharroubi AT, Darwish HM. Diabetes mellitus: The epidemic of the century. World J Diabetes. 2015 Jun 25;6(6):850-67. doi: 10.4239/wjd.v6.i6.850.
- Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet. 2017 Jun 3;389(10085):2239-2251. doi: 10.1016/S0140-6736(17)30058-2. Epub 2017 Feb 10. Erratum In: Lancet. 2017 Jun 3;389(10085):2192.
- Abdelwahab NS, Morsi A, Ahmed YM, Hassan HM, AboulMagd AM. Ecological HPLC method for analyzing an antidiabetic drug in real rat plasma samples and studying the effects of concurrently administered fenugreek extract on its pharmacokinetics. RSC Adv. 2021 Jan 25;11(8):4740-4750. doi: 10.1039/d0ra08836f. eCollection 2021 Jan 21.
- Ahmad A, Amir RM, Ameer K, Ali SW, Siddique F, Hayat I, Ahmad Z, Faiz F. 2020. Ameliorative effects of fenugreek (Trigonella foenum-graecum) seed on type 2 diabetes. Food Sci. Technol.(AHEAD).
- Ahmad H, Kashif S, Afreen A, Safdar M, Ahmed Z. 2021. Comparative effect of Fenugreek and Cinnamon on management of newly diagnosed cases of Type-2 Diabetes Mellitus. Food Sci. Technol.
- Alshali KZ. 2020. Review of herb supplement use in type 2 diabetes. Archives of Pharmacy Practice. 11(2).
- Ansari R, Ansari S. 2011. Effectiveness of fenugreek for lowering hemoglobin (HbA1c) in patients with self-management of type 2 diabetes: a randomized, controlled trial. Medical Complications of Type. 2: 393-412.
- Baset ME, Ali TI, Elshamy H, El Sadek AM, Sami DG, Badawy MT, Abou-Zekry SS, Heiba HH, Saadeldin MK, Abdellatif A. 2020. Anti-diabetic effects of fenugreek (Trigonella foenum-graecum): A comparison between oral and intraperitoneal administration - an animal study. Int J Funct Nutr. 1(1): 2.
- Das S, Dhananjaya BL, Desiraju S. 2018. Trigonella foenum-graceum (fenugreek) for Management of Diabetes. Int. j. biochem. res. 14(3): 1-10.
- Gupta RC, Chang D, Nammi S, Bensoussan A, Bilinski K, Roufogalis BD. Interactions between antidiabetic drugs and herbs: an overview of mechanisms of action and clinical implications. Diabetol Metab Syndr. 2017 Jul 26;9:59. doi: 10.1186/s13098-017-0254-9. eCollection 2017.
- Haber SL, Keonavong J. Fenugreek use in patients with diabetes mellitus. Am J Health Syst Pharm. 2013 Jul 15;70(14):1196, 1198, 1200, 1202-3. doi: 10.2146/ajhp120523. No abstract available.
- Hassani SS, Fallahi Arezodar F, Esmaeili SS, Gholami-Fesharaki M. Effect of Fenugreek Use on Fasting Blood Glucose, Glycosylated Hemoglobin, Body Mass Index, Waist Circumference, Blood Pressure and Quality of Life in Patients with Type 2 Diabetes Mellitus: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trials. Galen Med J. 2019 Mar 30;8:e1432. doi: 10.31661/gmj.v8i0.1432. eCollection 2019.
- Jiang JX, Zhu LW, Zhang WM, Sun RC. 2007. Characterization of Galactomannan Gum from Fenugreek (Trigonella foenum-graecum) Seeds and Its Rheological Properties. Int. J. Polym. 56(12): 1145-1154.
- Khursheed R, Singh SK, Wadhwa S, Kapoor B, Gulati M, Kumar R, Ramanunny AK, Awasthi A, Dua K. Treatment strategies against diabetes: Success so far and challenges ahead. Eur J Pharmacol. 2019 Nov 5;862:172625. doi: 10.1016/j.ejphar.2019.172625. Epub 2019 Aug 23.
- Kumar K, Kumar S, Datta A, Bandyopadhyay A. 2015. Effect of fenugreek seeds on glycemia and dyslipidemia in patients with type 2 diabetes mellitus. Int. j. health med. 4(7): 997-1000.
- Majeed M, Majeed S, Nagabhushanam K, Arumugam S, Natarajan S, Beede K, Ali F. Galactomannan from Trigonella foenum-graecum L. seed: Prebiotic application and its fermentation by the probiotic Bacillus coagulans strain MTCC 5856. Food Sci Nutr. 2018 Feb 20;6(3):666-673. doi: 10.1002/fsn3.606. eCollection 2018 May.
- Pandey H, Awasthi P. Effect of processing techniques on nutritional composition and antioxidant activity of fenugreek (Trigonella foenum-graecum) seed flour. J Food Sci Technol. 2015 Feb;52(2):1054-60. doi: 10.1007/s13197-013-1057-0. Epub 2013 Jun 12.
- Pradeep SR, Srinivasan K. Amelioration of hyperglycemia and associated metabolic abnormalities by a combination of fenugreek (Trigonella foenum-graecum) seeds and onion (Allium cepa) in experimental diabetes. J Basic Clin Physiol Pharmacol. 2017 Sep 26;28(5):493-505. doi: 10.1515/jbcpp-2015-0140.
- Ranade M, Mudgalkar N. A simple dietary addition of fenugreek seed leads to the reduction in blood glucose levels: A parallel group, randomized single-blind trial. Ayu. 2017 Jan-Jun;38(1-2):24-27. doi: 10.4103/ayu.AYU_209_15.
- Sanlier N, Gencer F. 2020. Role of spices in the treatment of diabetes mellitus: A minireview. Trends Food Sci Technol . 99: 441-449.
- Sarwar S, Hanif MA, Ayub MA, Boakye YD, Agyare C. 2020. Fenugreek. In. Medicinal Plants of South Asia. Elsevier. p. 257-271.
- Sharma R. 1986. Effect of fenugreek seeds and leaves on blood glucose and serum insulin responses in human subjects. Nutr Res 6(12): 1353-1364.
- Srinivasan K. 2019. Chapter 3.15 - Fenugreek (Trigonella foenum-graecum L.) Seeds Used as Functional Food Supplements to Derive Diverse Health Benefits. In: Nabavi SM, Silva AS, editors. Nonvitamin and Nonmineral Nutritional Supplements. Academic Press. p. 217-221.
- Standl E, Khunti K, Hansen TB, Schnell O. The global epidemics of diabetes in the 21st century: Current situation and perspectives. Eur J Prev Cardiol. 2019 Dec;26(2_suppl):7-14. doi: 10.1177/2047487319881021.
- Suchitra M, Parthasarathy S. 2015. Effect of administration of fenugreek seeds on HbA1C levels in uncontrolled diabetes mellitus-a randomized controlled trial. Int J Pharm Tech Res. 8(2): 180-182.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Raw versus Roasted Fenugreek
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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