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| ID | Type | Description | Link |
|---|---|---|---|
| R502-KR-ARU001-0000000090-K134 | Other Grant/Funding Number | Universiti Sains Malaysia |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overripe Banana Powder Formulation | Experimental | 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. |
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| Standard Nutritional Formulation | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overripe Banana Powder Formulation | Dietary Supplement | A nutritional formulation containing overripe banana powder. Participants consume the supplement once daily throughout the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose (mmol/L) | Change in fasting blood glucose (mmol/L) measured from baseline to the end of the 12-week intervention period. | Baseline and Week 12 |
| HbA1c (%) | Change in glycated hemoglobin (HbA1c) (%) levels measured to evaluate long-term glycaemic control from baseline to week 12. | Baseline and Week 12 |
| Fasting insulin (µIU/mL) | Change in fasting insulin concentration (µIU/mL) measured from baseline to the end of the 12-week intervention period. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance indices - HOMA-IR | Changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin concentrations from baseline to week 12. | Baseline and Week 12 |
| Insulin resistance indices - QUICKI |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity level (MET-minutes/week) | Physical activity was assessed using the validated Malay version of the Global Physical Activity Questionnaire (GPAQ). The data was processed according to the official International Physical Activity Questionnaire (IPAQ) scoring protocol. The results are reported as continuous scores expressed in Metabolic Equivalent of Task (MET)-minutes per week. Higher scores indicate a greater volume of physical activity expenditure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wan Rosli Wan Ishak, PhD | Nutrition and Dietetics Program, School of Health Sciences, Universiti Sains Malaysia Health Campus, Kubang Kerian, Kelantan, Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan | 16150 | Malaysia |
Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: an intervention group receiving overripe banana powder supplementation or a control group receiving the comparator treatment. The two groups will be followed concurrently throughout the study period, with outcome assessments conducted at baseline and at the end of the intervention.
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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.
| Standard Nutritional Formulation | Dietary Supplement | Participants consume the standard nutritional formulation once daily during the study period in addition to their usual diet and antidiabetic medication. |
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Changes in Quantitative Insulin-Sensitivity Check Index (QUICKI) calculated from fasting glucose and fasting insulin concentrations from baseline to week 12. |
| Baseline and week 12 |
| Body weight (kg) | Changes in body weight (kg) from baseline to week 12 | Baseline and week 12 |
| Body mass index (BMI) | Change in BMI. Weight (kg) and height (m) will be measured and combined to report BMI in kg/m² | Baseline and week 12 |
| Body fat percentage (%) | Body fat percentage (%) measured using body composition analyzer | Baseline and week 12 |
| Fat mass (kg) | Fat mass (kg) measured using body composition analyzer | Baseline and week 12 |
| Muscle mass (kg) | Muscle mass (kg) measured using body composition analyzer | Baseline and week 12 |
| Visceral fat rating | Visceral fat rating measured using body composition analyzer | Baseline and week 12 |
| Waist circumference (cm) | Waist circumference (cm) measured using measuring tape | Baseline and week 12 |
| Hip circumference (cm) | Hip circumference (cm) measured using measuring tape | Baseline and week 12 |
| Waist-Hip Ratio (WHR) | Waist-Hip Ratio (WHR) measured by waist circumference (cm) divided by hip circumference (cm). | Baseline and week 12 |
| Systolic blood pressure (mmHg) | Baseline and week 12 |
| Diastolic blood pressure (mmHg) | Baseline and week 12 |
| Total cholesterol (mmol/L) | Baseline and week 12 |
| 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 - Creatinine (µmol/L) | Baseline and week 12 |
| Renal function - eGFR (ml/min) | 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 - Sodium (mmol/L) | Baseline and week 12 |
| Renal function - Potassium (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 |
| Baseline and week 12 |
| Dietary - Total energy intake (kcal) | Change in average daily energy intake, assessed using 24-hour recalls and 3-day food records. Measured in kilocalories (kcal). | Baseline and week 12 |
| Dietary Carbohydrate Intake (g) | Change in average daily carbohydrate intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g) | Baseline and week 12 |
| Dietary Protein Intake (g) | Change in average daily protein intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g). | Baseline and week 12 |
| Dietary Fat Intake (g) | Change in average daily fat intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g). | Baseline and week 12 |
| Dietary Fibre Intake (g) | Change in average daily dietary fibre intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g) | Baseline and week 12 |
| Sugar intake (g) | Change in average daily sugar intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g) | Baseline and week 12 |
| Potassium Intake (mg) | Change in average daily potassium intake, assessed using 24-hour recalls and 3-day food records. Measured in milligrams (mg). | Baseline and week 12 |
| Sodium intake (mg) | Change in average daily sodium intake, assessed using 24-hour recalls and 3-day food records. Measured in milligrams (mg) | Baseline and week 12 |
| Diet quality - NCD Protect score | Diet quality will be assessed using the Diet Quality Questionnaire (DQQ). The NCD-Protect sub-score measures the consumption of health-protective food groups. Total scores range from 0 to 9. A higher score indicates greater consumption of health-promoting foods and better adherence to global dietary recommendations. | Baseline and week 12 |
| Diet quality - NCD Risk Score | Diet quality will be assessed using the Diet Quality Questionnaire (DQQ). The NCD-Risk sub-score measures the consumption of foods and drinks associated with an increased risk of non-communicable diseases, serving as a proxy measure for ultra-processed food consumption. Total scores range from 0 to 9. A higher score indicates a greater intake of foods to limit or avoid, reflecting worse diet quality. | Baseline and week 12 |
| Global Dietary Recommendation (GDR) Score | Overall diet quality will be assessed using the Diet Quality Questionnaire (DQQ) to calculate the GDR score. The GDR score evaluates overall adherence to the World Health Organization's healthy diet guidelines, combining both protective and risk dietary factors. Total scores range from 0 to 18. A higher score indicates a higher likelihood of meeting global dietary recommendations, reflecting a healthier overall diet. | Baseline and week 12 |