Skip to main content
OpenTrials
Completed

NCT Number: NCT07471607

Safety and Effectiveness of Overripe Banana Powder Added to Diabetic Formulas in Type 2 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Metabolic Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Overripe Banana Powder Formulation

Dietary Supplement

A nutritional formulation containing overripe banana powder. Participants consume the supplement once daily throughout the intervention period.

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.

Primary outcomes

  1. Fasting blood glucose (mmol/L)

    Time frame: Baseline and Week 12

    Change in fasting blood glucose (mmol/L) measured from baseline to the end of the 12-week intervention period.

  2. HbA1c (%)

    Time frame: Baseline and Week 12

    Change in glycated hemoglobin (HbA1c) (%) levels measured to evaluate long-term glycaemic control from baseline to week 12.

  3. Fasting insulin (µIU/mL)

    Time frame: Baseline and Week 12

    Change in fasting insulin concentration (µIU/mL) measured from baseline to the end of the 12-week intervention period.

Secondary outcomes

  1. Insulin resistance indices - HOMA-IR

    Time frame: 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.

  2. Insulin resistance indices - QUICKI

    Time frame: 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.

  3. Body weight (kg)

    Time frame: Baseline and week 12

    Changes in body weight (kg) from baseline to week 12

  4. Body mass index (BMI)

    Time frame: Baseline and week 12

    Change in BMI. Weight (kg) and height (m) will be measured and combined to report BMI in kg/m²

  5. Body fat percentage (%)

    Time frame: Baseline and week 12

    Body fat percentage (%) measured using body composition analyzer

  6. Fat mass (kg)

    Time frame: Baseline and week 12

    Fat mass (kg) measured using body composition analyzer

  7. Muscle mass (kg)

    Time frame: Baseline and week 12

    Muscle mass (kg) measured using body composition analyzer

  8. Visceral fat rating

    Time frame: Baseline and week 12

    Visceral fat rating measured using body composition analyzer

  9. Waist circumference (cm)

    Time frame: Baseline and week 12

    Waist circumference (cm) measured using measuring tape

  10. Hip circumference (cm)

    Time frame: Baseline and week 12

    Hip circumference (cm) measured using measuring tape

  11. Waist-Hip Ratio (WHR)

    Time frame: Baseline and week 12

    Waist-Hip Ratio (WHR) measured by waist circumference (cm) divided by hip circumference (cm).

  12. Systolic blood pressure (mmHg)

    Time frame: Baseline and week 12

  13. Diastolic blood pressure (mmHg)

    Time frame: Baseline and week 12

  14. Total cholesterol (mmol/L)

    Time frame: Baseline and week 12

  15. Triglyceride (mmol/L)

    Time frame: Baseline and week 12

  16. LDL-cholesterol (mmol/L)

    Time frame: Baseline and week 12

  17. HDL-cholesterol (mmol/L)

    Time frame: Baseline and week 12

  18. Renal function - Urea (mmol/L)

    Time frame: Baseline and week 12

  19. Renal function - Creatinine (µmol/L)

    Time frame: Baseline and week 12

  20. Renal function - eGFR (ml/min)

    Time frame: Baseline and week 12

  21. Renal function - calcium (mmol/L)

    Time frame: Baseline and week 12

  22. Renal function - Uric acid (mmol/L)

    Time frame: Baseline and week 12

  23. Renal function - Sodium (mmol/L)

    Time frame: Baseline and week 12

  24. Renal function - Potassium (mmol/L)

    Time frame: Baseline and week 12

  25. Renal function - Chloride (mmol/L)

    Time frame: Baseline and week 12

  26. Liver function - Total protein (g/L)

    Time frame: Baseline and week 12

  27. Liver function - Albumin (g/L)

    Time frame: Baseline and week 12

  28. Liver function - Globulin (g/L)

    Time frame: Baseline and week 12

  29. Liver function - A/G ratio

    Time frame: Baseline and week 12

  30. Liver function - Total bilirubin (U/L)

    Time frame: Baseline and week 12

  31. Liver function - Alkaline phosphatase ALP (U/L)

    Time frame: Baseline and week 12

  32. Liver function - Aspartate aminotransferase AST (U/L)

    Time frame: Baseline and week 12

  33. Liver function - Alanine aminotransferase ALT (U/L)

    Time frame: Baseline and week 12

Other outcomes

  1. Physical activity level (MET-minutes/week)

    Time frame: Baseline and week 12

    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.

  2. Dietary - Total energy intake (kcal)

    Time frame: Baseline and week 12

    Change in average daily energy intake, assessed using 24-hour recalls and 3-day food records. Measured in kilocalories (kcal).

  3. Dietary Carbohydrate Intake (g)

    Time frame: Baseline and week 12

    Change in average daily carbohydrate intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g)

  4. Dietary Protein Intake (g)

    Time frame: Baseline and week 12

    Change in average daily protein intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g).

  5. Dietary Fat Intake (g)

    Time frame: Baseline and week 12

    Change in average daily fat intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g).

  6. Dietary Fibre Intake (g)

    Time frame: Baseline and week 12

    Change in average daily dietary fibre intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g)

  7. Sugar intake (g)

    Time frame: Baseline and week 12

    Change in average daily sugar intake, assessed using 24-hour recalls and 3-day food records. Measured in grams (g)

  8. Potassium Intake (mg)

    Time frame: Baseline and week 12

    Change in average daily potassium intake, assessed using 24-hour recalls and 3-day food records. Measured in milligrams (mg).

  9. Sodium intake (mg)

    Time frame: Baseline and week 12

    Change in average daily sodium intake, assessed using 24-hour recalls and 3-day food records. Measured in milligrams (mg)

  10. Diet quality - NCD Protect score

    Time frame: Baseline and week 12

    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.

  11. Diet quality - NCD Risk Score

    Time frame: Baseline and week 12

    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.

  12. Global Dietary Recommendation (GDR) Score

    Time frame: Baseline and week 12

    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.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

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

Acronym: OBP-T2DM

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 13, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.