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

Universiti Sains Malaysia

Status: Completed

Conditions: Metabolic Disorders; Type 2 Diabetes

Treatments: Dietary Supplement: Standard Nutritional Formulation; Dietary Supplement: Overripe Banana Powder Formulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07471607

USM/JEPeM/KK/23070553

R502-KR-ARU001-0000000090-K134 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Overripe Banana Powder Formulation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Overripe Banana Powder Formulation

Standard Nutritional Formulation

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Standard Nutritional Formulation