Hyperglycemia, Obesity and Type 2 Diabetes, Type 2 Diabetes Mellitus (T2DM)
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERFenugreek Seed Powder
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.
Sponsors
University of Hail
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
All participants, care providers, and investigators were aware of the intervention.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline and 3 months after intervention | BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m²). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Blood Sugar (FBS) | Baseline and 3 months after intervention | Fasting blood sugar will be measured in mg/dL to assess glycemic control |
| Change in Random Blood Sugar (RBS) | Baseline and 3 months after intervention | Random blood sugar will be measured in mg/dL to evaluate fluctuations in blood glucose levels. |
| Change in Hemoglobin A1c (HbA1c) | Baseline and 3 months after intervention | HbA1c will be measured as a percentage to assess long-term glycemic control. |
Countries
Saudi Arabia
Outcome results
None listed