Foxtail Millet Based Dietary Intervention for Postprandial Glycemic Management Among Obese Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- DIABETES, lipid profile, weight, liver enzymes
研究概览
简要总结
This randomized controlled trial evaluated the effectiveness of foxtail millet (Setaria italica (L.) P. Beauv.) muffin supplementation on postprandial glycemic management among obese patients with type 2 diabetes mellitus. A total of 102 participants aged 30-60 years were randomly assigned to three groups for 10 weeks: T₀ (50 g wheat muffin with usual diet), T₁ (50 g foxtail millet muffin once daily), and T₂ (50 g foxtail millet muffin twice daily combined with a low glycemic index diet). Anthropometric indices, glycemic markers, lipid profile, and liver function parameters were assessed before and after intervention.
The results demonstrated significant improvements in metabolic outcomes, particularly in the T₂ group. Participants receiving foxtail millet muffins twice daily exhibited substantial reductions in body weight, BMI, fasting blood glucose, and HbA1c levels. Significant improvements were also observed in lipid parameters, including decreased total cholesterol, triglycerides, and LDL cholesterol, along with increased HDL cholesterol concentrations. Favorable changes in liver function markers further indicated enhanced metabolic health. Sensory evaluation confirmed good acceptability and palatability of the foxtail millet muffins. Overall, the findings suggest that regular consumption of foxtail millet muffins, especially when combined with a low glycemic index diet, is an effective dietary strategy for improving glycemic control, reducing obesity-related risk factors, and promoting metabolic health in obese diabetic patients.
详细描述
Type 2 diabetes mellitus (T2DM) and obesity are rapidly increasing public health concerns in Pakistan and are strongly associated with unhealthy dietary habits, excess body weight, and sedentary lifestyles. Functional foods with low glycemic properties have gained considerable attention as supportive dietary approaches for improving glycemic control and reducing diabetes-related complications. Foxtail millet (Setaria italica (L.) P. Beauv.) is a nutrient-dense cereal grain rich in dietary fiber, resistant starch, essential minerals, antioxidants, and slowly digestible carbohydrates, making it a promising candidate for glycemic management.
This randomized controlled trial investigated the effects of foxtail millet muffin supplementation on postprandial glycemic response and metabolic health among 102 obese diabetic patients aged 30-60 years. Participants were randomly allocated into three intervention groups for a period of 10 weeks. Group T₀ received a 50 g wheat muffin with their usual diet, Group T₁ received a 50 g foxtail millet muffin once daily, while Group T₂ received a 50 g foxtail millet muffin twice daily in combination with a low glycemic index dietary plan. Baseline and post-intervention assessments included anthropometric measurements, fasting blood glucose (FBG), glycated hemoglobin (HbA1c), lipid profile, and liver function parameters. The nutritional composition and sensory characteristics of the muffins were also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •i. Inclusion Criteria
- •People between 30 to 60 years old
- •Body Mass Index (BMI) ≥30.0 kg/m²
- •Fasting blood glucose levels ≥ 7.0 mmol/L (126 mg/dL)
- •Individuals having HbA1c ≥ 6.5%
- •Elevated Lipid Profile: TC > 200 mg/dL, TG > 150 mg/dL, LDL-C > 100 mg/dL, HDL-C < 40 mg/dL (men) / < 50 mg/dL (women)
- •Elevated Liver Function Tests: ALT > 56 U/L, AST > 40 U/L, ALP > 147 U/L, Total Bilirubin > 1.2 mg/dL, Albumin < 3.5 g/dL ii.
排除标准
- •Individuals who have a known allergy or have experienced any adverse reaction to foxtail millet or any of the ingredients used in the muffins will not be included in the study
- •Patients who are taking medications known to significantly alter glucose metabolism or gastrointestinal absorption
- •Individuals who have recently had gastric surgery or who have surgery planned during the research period
- •Presence of other severe chronic diseases (e.g., severe renal, hepatic, or cardiovascular disease, active cancer)
- •Nursing or pregnant females
研究组 & 干预措施
T2
one 50g Foxtail millet (Muffin) along with their low glycemic index diet, TWICE A DAY for 12 weeks
干预措施: T2 (Dietary Supplement)
T0
50g Wheat based (Muffin) along with their regular diet only per day for 12 weeks
干预措施: T0 (Dietary Supplement)
T1
one 50g Foxtail millet (Muffin) along with their low glycemic index diet, ONCE A DAY for 12 weeks
干预措施: T1 (Dietary Supplement)
结局指标
主要结局
DIABETES, lipid profile, weight, liver enzymes
时间窗: 12 WEEK
fasting glucose, HbA1c weight, lipid profile and LFT were checked on baseline and on 12 week of the study
次要结局
未报告次要终点