Safety and Effectiveness of Overripe Banana Powder Added to Diabetic Formulas in Type 2 Diabetes (OBP-T2DM)

Efficacy and Safety of Overripe Banana as an Adjunct to Specific Diabetic Formulas in Type 2 Diabetes Mellitus: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Metabolic Disorders
• Intervention / Treatment: Dietary supplement: Overripe Banana Powder Formulation; Dietary supplement: Standard Nutritional Formulation

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Overripe Banana Powder Formulation; A nutritional formulation containing overripe banana powder. Participants consume the supplement once daily throughout the intervention period.
Active Comparator: 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.	Dietary supplement: Standard Nutritional Formulation; Participants consume the standard nutritional formulation once daily during the study period in addition to their usual diet and antidiabetic medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Wan Rosli Wan Ishak, PhD, Nutrition and Dietetics Program, School of Health Sciences, Universiti Sains Malaysia Health Campus, Kubang Kerian, Kelantan, Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: March 6, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; Type 2 Diabetes Mellitus; dietary intervention; functional food; medical nutrition therapy; overripe banana
• Additional Relevant MeSH Terms: Endocrine System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Metabolic Diseases
• Other Study ID Numbers: USM/JEPeM/KK/23070553; R502-KR-ARU001-0000000090-K134 (Other Grant/Funding Number: Universiti Sains Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No