Type 2 DiabetesNCT05550870
Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients
A study testing Raw fenugreek seed powder and Roasted fenugreek seed powder in people with Type 2 Diabetes, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Raw fenugreek seed powder and Roasted fenugreek seed powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jan 2022to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 30-50 years of Type 2 Diabetic patients with past 5-15 years of diabetes Type 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Veterinary and Animal Sciences, Paksitan
Lahore, Punjab Province
About this study
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.
Read the 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
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
- Conditions
- Type 2 Diabetes
- Being tested
- Raw fenugreek seed powder, Roasted fenugreek seed powder
- Keywords
- Fenugreek, Diabetes, HbA1c, Hyperglycemia, Blood glucose, Raw versus Roasted fenugreek, Type 2 Diabetes, Lipid profile, Cholesterol, Triglycerides, HDL, LDL
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raw fenugreek seed powderDietary supplement
It will be given to group 1
Roasted fenugreek seed powderDietary supplement
It will be given to group 2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Roasted fenugreek seed powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expected change in the level of HbA1c .
HbA1c will be assessed after three months of trial through a blood sample
Measured: 3 months
Weight will be checked in kg
weight machine will be used to assess weight in both groups after 3 months
Measured: 3 months
BMI will be checked in kg/^2
BMI after study will be assessed as kg/m2
Measured: 3 months
Fasting Blood Sugar in mg/dl
After every two weeks the fasting blood sugar will be assessed via Glucometer
Measured: Bimonthly till 3 months
Random Blood Sugar in mg/dl
Bimonthly Random blood sugar will be assessed via Glucometer
Measured: Bimonthly till 3 months
HDL in mg/dl
High Density Lipoprotein-Cholesterol will be assessed after the study in a private lab
Measured: 3 months
LDL in mg/dl
Low Density Lipoprotein-Cholesterol will be tested after the intervention period
Measured: 3 months
Triglycerides in mg/dl
Triglycerides will be tested after the intervention period
Measured: 3 months
Cholesterol in mg/dl
Cholesterol will be tested after the intervention period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start24 Jan 2022
- Primary completion27 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanaullah Iqbal, University of Veterinary and Animal Sciences, Lahore - Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550870
- Sponsor's protocol ID
- Raw versus Roasted Fenugreek
- Status last verified
- Jun 2023
- First submitted
- 20 Jun 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35424379Ahmad 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).
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.
PubMed 20042775Ansari 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.
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.
PubMed 28190580Das 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.
PubMed 28770011Haber 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.
PubMed 23820455Hassani 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.
PubMed 34466512Jiang 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.
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.
PubMed 26131326Khursheed 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.
PubMed 31449807
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Raw Versus Roasted Fenugreek Seed Powder in Reducing Blood Glucose Levels in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT05550870
- Acronym / sponsor ID
- Raw versus Roasted Fenugreek
- Conditions
- Type 2 Diabetes
- Keywords
- Fenugreek, Diabetes, HbA1c, Hyperglycemia, Blood glucose, Raw versus Roasted fenugreek, Type 2 Diabetes, Lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Veterinary and Animal Sciences, Lahore - PakistanUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: Raw fenugreek seed powderGroup 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. |
| Group 2 | Experimental | Dietary Supplement: Roasted fenugreek seed powderGroup 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 30-50 years of Type 2 Diabetic patients with past 5-15 years of diabetes Type 2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Raw fenugreek seed powderIt will be given to group 1 | Dietary supplement | Group 1 |
| Roasted fenugreek seed powderIt will be given to group 2 | Dietary supplement | Group 2 |
Primary outcome
Expected change in the level of HbA1c .
Time frame: 3 months
HbA1c will be assessed after three months of trial through a blood sample
Weight will be checked in kg
Time frame: 3 months
weight machine will be used to assess weight in both groups after 3 months
BMI will be checked in kg/^2
Time frame: 3 months
BMI after study will be assessed as kg/m2
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
Random Blood Sugar in mg/dl
Time frame: Bimonthly till 3 months
Bimonthly Random blood sugar will be assessed via Glucometer
HDL in mg/dl
Time frame: 3 months
High Density Lipoprotein-Cholesterol will be assessed after the study in a private lab
LDL in mg/dl
Time frame: 3 months
Low Density Lipoprotein-Cholesterol will be tested after the intervention period
Triglycerides in mg/dl
Time frame: 3 months
Triglycerides will be tested after the intervention period
Cholesterol in mg/dl
Time frame: 3 months
Cholesterol will be tested after the intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 35424379Abdelwahab 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.
- BackgroundAhmad 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).
- BackgroundAhmad 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.
- BackgroundAlshali KZ. 2020. Review of herb supplement use in type 2 diabetes. Archives of Pharmacy Practice. 11(2).
- Background: PubMed 20042775American 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.
- BackgroundAnsari 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.
- BackgroundBaset 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: PubMed 28190580Chatterjee 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.
- BackgroundDas S, Dhananjaya BL, Desiraju S. 2018. Trigonella foenum-graceum (fenugreek) for Management of Diabetes. Int. j. biochem. res. 14(3): 1-10.
- Background: PubMed 28770011Gupta 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.
- Background: PubMed 23820455Haber 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.
- Background: PubMed 34466512Hassani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Raw fenugreek seed powder and Roasted fenugreek seed powder in people with Type 2 Diabetes, run by University of Veterinary and Animal Sciences, Lahore - Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expected change in the level of HbA1c . (time frame: 3 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550870, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.