A Randomized Controlled Clinical Trial Evaluating the Efficacy of a Millet-Based Formulation on Glycemic Regulation and Nutritional Status in Patients with Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change in HbA1c, FBS, PPBS, and OGTT response
研究概览
简要总结
Background: Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder marked by insulin resistance and hyperglycemia, often leading to vascular and metabolic complications. Dietary modification plays a critical role in its management. Millets, particularly Panicum sumatrense, are rich in fibre, slowly digestible starches, micronutrients, and antioxidants, with a low glycemic index. However, robust clinical evidence on their effect in T2DM is limited.
Objective: To evaluate the efficacy of a millet-based formulation as a dietary adjunct on glycemic control and nutritional status in patients with T2DM.
Methods: This is a 90-day, randomized, open-label, two-arm, parallel-group controlled clinical trial conducted at a dedicated clinical research unit. Ninety-four participants with T2DM (HbA1c 6.5–9.0%, aged 30–70 years) will be randomized (1:1) into intervention (n=47) and control (n=47) groups. The intervention group will receive 150 g of a millet-based formulation at night, replacing regular dinner, along with standard diabetic care; the control group will receive standard care only. Assessments will be performed at baseline, Day 45, and Day 90.
Primary Endpoints: Changes in glycemic parameters (HbA1c, Fasting Blood Sugar, Postprandial Blood Sugar, Oral Glucose Tolerance Test) and nutritional biomarkers (Vitamins A, B2, B6, B12, D3; microminerals: Mg, Ca, Zn, P, Mn, Cu, Se).
Secondary Endpoints: Changes in liver and renal function tests, lipid and hematological profiles, and quality of life (QOL) using a validated diabetes-specific scale.
Analysis: Between-group differences will be evaluated using independent t-tests/Mann-Whitney U tests, with repeated measures ANOVA or mixed models for longitudinal analysis. Both intention-to-treat and per-protocol analyses will be performed.
Expected Outcomes: The millet-based formulation is anticipated to improve glycemic control, enhance vitamin and mineral bioavailability, positively modulate biochemical parameters, and improve QOL in T2DM patients.
Conclusion: This trial will provide scientific evidence on the role of millet-based formulations as a sustainable, low-cost dietary intervention for glycemic regulation and nutritional improvement in T2DM management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 30–70 years Diagnosed with Type 2 Diabetes Mellitus (as per ADA 2023 guidelines) HbA1c between 6.5% and 9.0% On stable oral hypoglycemic agents for at least 3 months Willing to replace dinner with study formulation Provided written informed consent.
排除标准
- •Insulin-dependent diabetics Chronic liver, kidney, thyroid dysfunction or cardiac diseases History of gastrointestinal disorders Allergy to millets or cereal grains Pregnant or lactating women Participation in other clinical trials in the last 3 months.
结局指标
主要结局
Change in HbA1c, FBS, PPBS, and OGTT response
时间窗: Baseline (0th day) and Day 90
Change in vitamins (A, B2, B6, B12, D3) and microminerals (Magnesium, Calcium, Zinc, Phosphorus, Manganese, Copper, Selenium)
时间窗: Baseline (0th day) and Day 90
次要结局
- Change in Liver Function Tests (LFT), Renal Function Tests (RFT), and Lipid profile (TC, LDL, HDL, TG)(Change in hematological profile (CBC) and Quality of Life (QOL) using a validated diabetes-specific QOL scale)
研究者
Dr J Hareendran Nair
Pankajakasthuri Herbal Research Foundation