Metabolic Disorders, Type 2 Diabetes
Conditions
Keywords
overripe banana, functional food, dietary intervention, medical nutrition therapy, randomized controlled trial, Type 2 Diabetes Mellitus
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOverripe Banana Powder Formulation
A nutritional formulation containing overripe banana powder. Participants consume the supplement once daily throughout the intervention period.
DIETARY_SUPPLEMENTStandard Nutritional Formulation
Participants consume the standard nutritional formulation once daily during the study period in addition to their usual diet and antidiabetic medication.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c (%) | 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) | Baseline and Week 12 | Change in fasting insulin concentration (µIU/mL) measured from baseline to the end of the 12-week intervention period. |
| Fasting blood glucose (mmol/L) | Baseline and Week 12 | Change in fasting blood glucose (mmol/L) measured from baseline to the end of the 12-week intervention period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance indices - HOMA-IR | Baseline and Week 12 | Changes in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin concentrations from baseline to week 12. |
| Insulin resistance indices - QUICKI | Baseline and week 12 | Changes in Quantitative Insulin-Sensitivity Check Index (QUICKI) calculated from fasting glucose and fasting insulin concentrations from baseline to week 12. |
| Body weight (kg) | Baseline and week 12 | Changes in body weight (kg) from baseline to week 12 |
| Body mass index (BMI) | Baseline and week 12 | Change in BMI. Weight (kg) and height (m) will be measured and combined to report BMI in kg/m² |
| Body fat percentage (%) | Baseline and week 12 | Body fat percentage (%) measured using body composition analyzer |
| Fat mass (kg) | Baseline and week 12 | Fat mass (kg) measured using body composition analyzer |
| Muscle mass (kg) | Baseline and week 12 | Muscle mass (kg) measured using body composition analyzer |
| Visceral fat rating | Baseline and week 12 | Visceral fat rating measured using body composition analyzer |
| Waist circumference (cm) | Baseline and week 12 | Waist circumference (cm) measured using measuring tape |
| Hip circumference (cm) | Baseline and week 12 | Hip circumference (cm) measured using measuring tape |
| Waist-Hip Ratio (WHR) | Baseline and week 12 | Waist-Hip Ratio (WHR) measured by waist circumference (cm) divided by hip circumference (cm). |
| 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 | — |
Countries
Malaysia
Contacts
PRINCIPAL_INVESTIGATORWan Rosli Wan Ishak, PhD
Nutrition and Dietetics Program, School of Health Sciences, Universiti Sains Malaysia Health Campus, Kubang Kerian, Kelantan, Malaysia
Outcome results
None listed