Impact of Fenugreek Supplementation on Obesity and Hyperglycemia Among Diabetic Adults in Saudi Arabia: A Quasi-Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Body Mass Index (BMI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All participants, care providers, and investigators were aware of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1: Fenugreek Supplementation
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.
干预措施: Fenugreek Seed Powder (Other)
Arm 2: Standard Care Only
40 Participants in this group continued their usual diabetes treatment and followed a standard meal plan. They did not receive the Fenugreek supplement.
结局指标
主要结局
Change in Body Mass Index (BMI)
时间窗: Baseline and 3 months after intervention
BMI will be calculated as weight in kilograms divided by the square of height in meters (kg/m²).
次要结局
- Change in Fasting Blood Sugar (FBS)(Baseline and 3 months after intervention)
- Change in Random Blood Sugar (RBS)(Baseline and 3 months after intervention)
- Change in Hemoglobin A1c (HbA1c)(Baseline and 3 months after intervention)