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

NCT07471607 | Completed DMC

• 2 other identifiers: USM/JEPeM/KK/23070553R502-KR-ARU001-0000000090-K134
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Metabolic Disorders

Keywords

overripe banana; functional food; dietary intervention; medical nutrition therapy; randomized controlled trial; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (33)

• 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

Other Outcomes (12)

• Physical activity level (MET-minutes/week)

  Baseline and week 12

• Dietary - Total energy intake (kcal)

  Baseline and week 12

• Dietary Carbohydrate Intake (g)

  Baseline and week 12

Study Arms (2)

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.

Dietary Supplement: Overripe Banana Powder Formulation

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.

Dietary Supplement: Standard Nutritional Formulation

Interventions

Overripe Banana Powder Formulation DIETARY_SUPPLEMENT

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

Overripe Banana Powder Formulation

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.

Standard Nutritional Formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Wan Rosli Wan Ishak, PhD

  Nutrition and Dietetics Program, School of Health Sciences, Universiti Sains Malaysia Health Campus, Kubang Kerian, Kelantan, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of School of Health Sciences, USM Health Campus

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)