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

NCT05550870 | Completed

• 1 other identifier: Raw versus Roasted Fenugreek
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Fenugreek; Diabetes; HbA1c; Hyperglycemia; Blood glucose; Raw versus Roasted fenugreek; Type 2 Diabetes; Lipid profile; Cholesterol; Triglycerides; HDL; LDL

Outcome Measures

Primary Outcomes (9)

• Expected change in the level of HbA1c .

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

  3 months

• Weight will be checked in kg

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

  3 months

• BMI will be checked in kg/^2

  BMI after study will be assessed as kg/m2

  3 months

• Fasting Blood Sugar in mg/dl

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

  Bimonthly till 3 months

• Random Blood Sugar in mg/dl

  Bimonthly Random blood sugar will be assessed via Glucometer

  Bimonthly till 3 months

• HDL in mg/dl

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

  3 months

• LDL in mg/dl

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

  3 months

• Triglycerides in mg/dl

  Triglycerides will be tested after the intervention period

  3 months

• Cholesterol in mg/dl

  Cholesterol will be tested after the intervention period

  3 months

Study Arms (2)

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.

Dietary Supplement: Raw fenugreek seed powder

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.

Dietary Supplement: Roasted fenugreek seed powder

Interventions

Raw fenugreek seed powder DIETARY_SUPPLEMENT

It will be given to group 1

Group 1

Roasted fenugreek seed powder DIETARY_SUPPLEMENT

It will be given to group 2

Group 2

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Veterinary and Animal Sciences, Lahore - Pakistan: lead

Study Sites (1)

University of Veterinary and Animal Sciences, Paksitan

Lahore, Punjab Province, Pakistan

Location

Related Publications (26)

• 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.

  PMID: 35424379 BACKGROUND

• 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).

  BACKGROUND

• 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.

  BACKGROUND

• Alshali KZ. 2020. Review of herb supplement use in type 2 diabetes. Archives of Pharmacy Practice. 11(2).

  BACKGROUND

• 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.

  PMID: 20042775 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28190580 BACKGROUND

• Das S, Dhananjaya BL, Desiraju S. 2018. Trigonella foenum-graceum (fenugreek) for Management of Diabetes. Int. j. biochem. res. 14(3): 1-10.

  BACKGROUND

• 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.

  PMID: 28770011 BACKGROUND

• 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.

  PMID: 23820455 BACKGROUND

• 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.

  PMID: 34466512 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26131326 BACKGROUND

• 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.

  PMID: 31449807 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29876118 BACKGROUND

• 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.

  PMID: 25694718 BACKGROUND

• 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.

  PMID: 28599386 BACKGROUND

• 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.

  PMID: 29861588 BACKGROUND

• Sanlier N, Gencer F. 2020. Role of spices in the treatment of diabetes mellitus: A minireview. Trends Food Sci Technol . 99: 441-449.

  BACKGROUND

• Sarwar S, Hanif MA, Ayub MA, Boakye YD, Agyare C. 2020. Fenugreek. In. Medicinal Plants of South Asia. Elsevier. p. 257-271.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31766915 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: September 22, 2022
• Study Start: January 24, 2022
• Primary Completion: May 27, 2022
• Study Completion: May 30, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)