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The goal of this clinical trial is to learn if Fenugreek seed powder helps lower body weight and blood sugar in adults with type 2 diabetes who are overweight or obese. The main questions it aims to answer are:
Does Fenugreek lower body mass index (BMI)? Does Fenugreek lower fasting blood sugar, random blood sugar, and HbA1c levels? Researchers will compare people who take Fenugreek along with their regular diabetes care to people who receive only standard diabetes care, to see if the Fenugreek supplement adds extra benefits.
Participants will:
Take 10 grams of Fenugreek seed powder twice a day (before breakfast and dinner) for 3 months.
Follow their usual diabetes treatment and a recommended meal plan. Visit the clinic four times during the study to check weight and blood sugar levels.
This study is being done in Hail City, Saudi Arabia.
This clinical trial tested whether Fenugreek seed powder, a natural dietary supplement, could help lower blood sugar and reduce body weight in adults with type 2 diabetes. The study was conducted in Hail City, Saudi Arabia, and involved 80 participants who were either overweight or obese and diagnosed with type 2 diabetes.
Participants were assigned to one of two groups:
The intervention group received 10 grams of Fenugreek seed powder twice daily (before breakfast and dinner) for three months, in addition to their usual diabetes treatment and a standard meal plan.
The control group received only their standard diabetes care and meal plan, without the Fenugreek supplement.
The study used a quasi-experimental pretest-posttest design. Participants' weight (BMI), fasting blood sugar (FBS), random blood sugar (RBS), and HbA1c were measured at the start and monitored throughout the three-month period. Data were collected from local clinics and hospitals that serve people with diabetes in the region.
This study aims to provide evidence on the potential role of Fenugreek as a safe, culturally accepted, and cost-effective supplement that can support diabetes management and reduce obesity-related complications in the Saudi population
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Fenugreek Supplementation | Experimental | 40 Participants in this group received 10 grams of Fenugreek seed powder twice daily (before breakfast and dinner) for 3 months, in addition to their usual diabetes treatment and a standard meal plan. |
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| Arm 2: Standard Care Only | No Intervention | 40 Participants in this group continued their usual diabetes treatment and followed a standard meal plan. They did not receive the Fenugreek supplement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenugreek Seed Powder | Other | Participants in the intervention group received 10 grams of ground Fenugreek seed powder, administered twice daily (before breakfast and dinner), for a total of 3 months. The Fenugreek powder was consumed mixed with water, in addition to the participants' regular antidiabetic medications and a standardized meal plan. The supplement was provided in a non-encapsulated, natural powdered form, and was not combined with any other herbal or pharmaceutical products. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index (BMI) | BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m²). | Baseline and 3 months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Blood Sugar (FBS) | Fasting blood sugar will be measured in mg/dL to assess glycemic control | Baseline and 3 months after intervention |
| Change in Random Blood Sugar (RBS) | Random blood sugar will be measured in mg/dL to evaluate fluctuations in blood glucose levels. |
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Inclusion Criteria:
Adults aged 18 years or older
Diagnosed with type 2 diabetes mellitus
Body Mass Index (BMI) classified as overweight or obese
Receiving standard diabetes treatment (e.g., oral hypoglycemic agents)
Able and willing to provide informed consent
Residing in Hail City, Saudi Arabia
Exclusion Criteria:
Diagnosed with type 1 diabetes mellitus
Currently using insulin therapy
Pregnant or breastfeeding women
Known allergy or sensitivity to Fenugreek
Diagnosed gastrointestinal diseases or malabsorption conditions
Participation in another clinical trial within the past 3 months
Any serious medical or psychiatric condition that, in the opinion of the investigators, could interfere with study participation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hail | Ha'il | 55424 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24438170 | Result | Neelakantan N, Narayanan M, de Souza RJ, van Dam RM. Effect of fenugreek (Trigonella foenum-graecum L.) intake on glycemia: a meta-analysis of clinical trials. Nutr J. 2014 Jan 18;13:7. doi: 10.1186/1475-2891-13-7. |
| Label | URL |
|---|---|
| Related Info | View source |
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There is no plan to share individual participant data (IPD) with other researchers.
The data collected will be used solely for the purposes outlined in the approved research protocol and will remain confidential.
Any future data sharing (if considered) would require additional ethical clearance and participant consent.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 10, 2025 | Jun 17, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Participants were assigned to one of two parallel groups. One group received Fenugreek seed powder along with standard diabetes treatment, while the other group received standard treatment only. Each participant remained in their assigned group for the full duration of the 3-month study period, with no crossover between groups.
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All participants, care providers, and investigators were aware of the intervention.
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|
| Baseline and 3 months after intervention |
| Change in Hemoglobin A1c (HbA1c) | HbA1c will be measured as a percentage to assess long-term glycemic control. | Baseline and 3 months after intervention |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |