Effect of Ajwa Seed Powder on HbA1c and Body Composition in Overweight and Obese Patients With Type 2 Diabetes Mellitus: A Single-Arm Interventional Stuy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- change in HbA1c concentration (%) from baseline to week 12 in 30 overweight and obese patients with type 2 diabetes mellitus
研究概览
简要总结
The goal of this interventional study (clinical trial) is to check if ajwa seed powder can treat type 2 diabetes mellitus in overweight and and obese patients with type 2 diabetes mellitus including both male and female of the age group between 30-50. The main question is what would be the impact of ajwa seed powder on HbA1c and body composition in overweight and obese patients with type 2 diabetes mellitus which aim to
result in better glycemic control particular Hba1c, and body composition improvement in type 2 diabetes mellitus patients
Participants will be asked to consume 4 grams of ajwa seed powder per day
详细描述
Background:
Ajwa seeds (Phoenix dactylifera L.) exhibit anti-obesity, antihyperglycemic, and antioxidative activities, with enhancements in body composition and HbA1c levels. However, there have been very few studies investigating the combined impact of these activities in obese or overweight diabetic individuals. Therefore, the aim of this study is to examine the impact of Ajwa seed powder on body composition and HbA1c levels among this group of individuals. The study supports sustainable development goals 2 & 3 (Zero Hunger, Good Health and well-being) respectively.
Research Questions
• What would be the impact of ajwa seed powder on HbA1c and body composition in overweight and obese patients with type 2 diabetes mellitus?
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30-50 years
- •Gender: Male/female
- •Body Mass Index (BMI): 25-35 kg/m²
- •Type 2 diabetes mellitus: HbA1c ≥ 6.5%
排除标准
- •History of alcoholic liver disease or cirrhosis; liver dysfunction based on initial blood tests
- •Patients being treated with insulin
- •High initial levels of serum creatinine (men>1.5 mg/dl; women>1.2 mg/dl)
- •Pregnant/lactating females or women who cannot take proper contraceptive measures
- •Symptoms consistent with peptic ulcer disease or history of peptic ulcers
- •Active cancer patients
- •Severe non-diabetes-related illnesses
- •Patients with heart, liver, or lung failures
- •Patients with blood disorders or on anticoagulant drugs such as warfarin Any other disease as decided by the principal investigator, which might put the safety of the subjects at risk while conducting the test
研究组 & 干预措施
Ajwa Seed powder group
This will be Single Arm interventional Study in which overweight or obese adults aged 30-50 years with Type 2 Diabetes (HbA1c >6.5% and BMI 25-35 kg/m²) will receive Ajwa seed powder supplementation (4 g/day in the form of capsules or sachets) for 12 weeks. HbA1c levels and body composition parameters, including body weight, BMI, waist/hip circumference, fat mass, fat-free mass, visceral fat, and muscle mass, will be assessed before and after the intervention using an InBody bioelectrical impedance analyzer.
干预措施: Ajwa Seed powder (Dietary Supplement)
结局指标
主要结局
change in HbA1c concentration (%) from baseline to week 12 in 30 overweight and obese patients with type 2 diabetes mellitus
时间窗: 12 weeks
次要结局
- Weight in kg(12 weeks)
- Height in meter(12 weeks)
- Waist circumference in cm(12 weeks)
- Hip circumference in cm(12 weeks)
- Fat free mass in kg(12 weeks)
- Visceral fat level in cm²(12 weeks)