Efficacy and Safety of Overripe Banana as an Adjunct to Specific Diabetic Formulas in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fasting blood glucose (mmol/L)
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effects of overripe banana powder supplementation on metabolic parameters among patients with type 2 diabetes mellitus (T2DM). Dietary management plays a crucial role in glycaemic control for individuals with T2DM, and the identification of functional food ingredients with potential metabolic benefits has gained increasing research interest. Overripe banana contains various bioactive compounds including resistant starch, dietary fiber, and polyphenols, which may contribute to improved glycaemic regulation and metabolic outcomes.
Participants diagnosed with T2DM will be randomly assigned to receive either a nutritional intervention or control supplementation for a defined intervention period. The intervention involves daily consumption of a measured dose of overripe banana powder incorporated into the participants' diet. Clinical and biochemical parameters will be assessed at baseline and after the intervention period to evaluate potential metabolic changes.
Primary outcomes include indicators of glycaemic control such as fasting blood glucose and glycated hemoglobin (HbA1c). Secondary outcomes include changes in blood pressure and other metabolic parameters. The findings of this study may provide evidence on the potential role of overripe banana-derived functional ingredients as a dietary strategy for improving metabolic health among individuals with T2DM.
详细描述
as are widely consumed fruits that contain carbohydrates, dietary fiber, resistant starch, and polyphenolic compounds. During the ripening process, biochemical changes occur that may influence the functional properties of the fruit. Overripe bananas may contain specific bioactive compounds that have the potential to influence glucose metabolism, insulin sensitivity, and other metabolic pathways.
This randomized controlled trial is designed to investigate the metabolic effects of overripe banana powder supplementation in individuals with T2DM. Eligible participants diagnosed with T2DM will be recruited and randomly allocated into intervention and control groups. Participants in the intervention group will receive a daily dose of overripe banana powder, while the control group will receive a comparator nutritional supplement. The intervention will be administered for a defined study duration.
Clinical assessments and biochemical measurements will be conducted at baseline and after completion of the intervention period. Key metabolic outcomes include fasting blood glucose, glycated hemoglobin (HbA1c), blood pressure, and other metabolic indicators. Dietary intake and lifestyle factors may also be monitored to minimize confounding effects.
The results of this study will contribute to the understanding of the potential role of overripe banana-based nutritional interventions in improving metabolic outcomes among patients with T2DM. This research may provide evidence supporting the development of functional food strategies as complementary approaches for diabetes management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This was an open-label trial in which participants and investigators were aware of treatment allocation after randomization due to the distinct sensory characteristics of the intervention product. However, follow-up outcome assessments were conducted by trained physicians and nurses who were blinded to treatment allocation. In addition, statisticians remained blinded during data cleaning and analysis, with treatment groups coded until analyses were completed.
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 diagnosed with Type 2 Diabetes Mellitus (T2DM)
- •HbA1c between 6.5% and 10% at baseline
- •Fasting blood glucose <15 mmol/L
- •Body mass index (BMI) ≥23 kg/m²
- •Non-insulin-dependent T2DM
- •On a stable antidiabetic medication regimen for at least 3 months prior to enrolment
排除标准
- •Pregnant or lactating women
- •Individuals receiving insulin therapy
- •History of drug or alcohol abuse
- •Serious mental disorders
- •Presence of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, or infectious diseases that may interfere with study participation
研究组 & 干预措施
Overripe Banana Powder Formulation
Participants in this group receive a nutritional supplement formulation in which a portion of the standard formulation is replaced with 5g overripe banana powder (1:1 ratio). The formulation is consumed once daily during the intervention period in addition to usual antidiabetic medication and standard clinical care.
干预措施: Overripe Banana Powder Formulation (Dietary Supplement)
Standard Nutritional Formulation
Participants in the control group receive the standard nutritional formulation without overripe banana powder. The supplement is consumed once daily during the intervention period in addition to usual antidiabetic medication and standard clinical care.
干预措施: Standard Nutritional Formulation (Dietary Supplement)
结局指标
主要结局
Fasting blood glucose (mmol/L)
时间窗: Baseline and Week 12
Change in fasting blood glucose (mmol/L) measured from baseline to the end of the 12-week intervention period.
HbA1c (%)
时间窗: Baseline and Week 12
Change in glycated hemoglobin (HbA1c) (%) levels measured to evaluate long-term glycaemic control from baseline to week 12.
Fasting insulin (µIU/mL)
时间窗: Baseline and Week 12
Change in fasting insulin concentration (µIU/mL) measured from baseline to the end of the 12-week intervention period.
次要结局
- Triglyceride (mmol/L)(Baseline and week 12)
- LDL-cholesterol (mmol/L)(Baseline and week 12)
- HDL-cholesterol (mmol/L)(Baseline and week 12)
- Renal function - Urea (mmol/L)(Baseline and week 12)
- Renal function - Potassium (mmol/L)(Baseline and week 12)
- Renal function - Creatinine (µmol/L)(Baseline and week 12)
- Renal function - eGFR (ml/min)(Baseline and week 12)
- Total cholesterol (mmol/L)(Baseline and week 12)
- Renal function - Sodium (mmol/L)(Baseline and week 12)
- Insulin resistance indices - HOMA-IR(Baseline and Week 12)
- Insulin resistance indices - QUICKI(Baseline and week 12)
- Body weight (kg)(Baseline and week 12)
- Body mass index (BMI)(Baseline and week 12)
- Body fat percentage (%)(Baseline and week 12)
- Fat mass (kg)(Baseline and week 12)
- Muscle mass (kg)(Baseline and week 12)
- Visceral fat rating(Baseline and week 12)
- Waist circumference (cm)(Baseline and week 12)
- Hip circumference (cm)(Baseline and week 12)
- Waist-Hip Ratio (WHR)(Baseline and week 12)
- Systolic blood pressure (mmHg)(Baseline and week 12)
- Diastolic blood pressure (mmHg)(Baseline and week 12)
- Renal function - calcium (mmol/L)(Baseline and week 12)
- Renal function - Uric acid (mmol/L)(Baseline and week 12)
- Renal function - Chloride (mmol/L)(Baseline and week 12)
- Liver function - Total protein (g/L)(Baseline and week 12)
- Liver function - Albumin (g/L)(Baseline and week 12)
- Liver function - Globulin (g/L)(Baseline and week 12)
- Liver function - A/G ratio(Baseline and week 12)
- Liver function - Total bilirubin (U/L)(Baseline and week 12)
- Liver function - Alkaline phosphatase ALP (U/L)(Baseline and week 12)
- Liver function - Aspartate aminotransferase AST (U/L)(Baseline and week 12)
- Liver function - Alanine aminotransferase ALT (U/L)(Baseline and week 12)
研究者
Wan Rosli Wan Ishak
Dean of School of Health Sciences, USM Health Campus
Universiti Sains Malaysia