Type 2 DiabetesOBP-T2DMNCT07471607
Safety and Effectiveness of Overripe Banana Powder Added to Diabetic Formulas in Type 2 Diabetes
A study testing Overripe Banana Powder Formulation and Standard Nutritional Formulation in people with Type 2 Diabetes and Metabolic Disorders, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Metabolic Disorders
- What is being tested?
- Overripe Banana Powder Formulation and Standard Nutritional Formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Metabolic Disorders
- Being tested
- Overripe Banana Powder Formulation, Standard Nutritional Formulation
- Keywords
- overripe banana, functional food, dietary intervention, medical nutrition therapy, randomized controlled trial, Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overripe Banana Powder FormulationDietary supplement
A nutritional formulation containing overripe banana powder. Participants consume the supplement once daily throughout the intervention period.
Standard Nutritional FormulationDietary supplement
Participants consume the standard nutritional formulation once daily during the study period in addition to their usual diet and antidiabetic medication.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Standard Nutritional Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose (mmol/L)
Change in fasting blood glucose (mmol/L) measured from baseline to the end of the 12-week intervention period.
Measured: Baseline and Week 12
HbA1c (%)
Change in glycated hemoglobin (HbA1c) (%) levels measured to evaluate long-term glycaemic control from baseline to week 12.
Measured: 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.
Measured: Baseline and Week 12
Secondary outcomes (33)
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.
Measured: 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.
Measured: Baseline and week 12
Body weight (kg)
Changes in body weight (kg) from baseline to week 12
Measured: 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
Measured: Baseline and week 12
Body fat percentage (%)
Body fat percentage (%) measured using body composition analyzer
Measured: Baseline and week 12
Fat mass (kg)
Fat mass (kg) measured using body composition analyzer
Measured: Baseline and week 12
Muscle mass (kg)
Muscle mass (kg) measured using body composition analyzer
Measured: Baseline and week 12
Visceral fat rating
Visceral fat rating measured using body composition analyzer
Measured: Baseline and week 12
Waist circumference (cm)
Waist circumference (cm) measured using measuring tape
Measured: Baseline and week 12
Hip circumference (cm)
Hip circumference (cm) measured using measuring tape
Measured: Baseline and week 12
Waist-Hip Ratio (WHR)
Waist-Hip Ratio (WHR) measured by waist circumference (cm) divided by hip circumference (cm).
Measured: Baseline and week 12
Systolic blood pressure (mmHg)
Measured: Baseline and week 12
Diastolic blood pressure (mmHg)
Measured: Baseline and week 12
Total cholesterol (mmol/L)
Measured: Baseline and week 12
Triglyceride (mmol/L)
Measured: Baseline and week 12
LDL-cholesterol (mmol/L)
Measured: Baseline and week 12
HDL-cholesterol (mmol/L)
Measured: Baseline and week 12
Renal function - Urea (mmol/L)
Measured: Baseline and week 12
Renal function - Creatinine (µmol/L)
Measured: Baseline and week 12
Renal function - eGFR (ml/min)
Measured: Baseline and week 12
Renal function - calcium (mmol/L)
Measured: Baseline and week 12
Renal function - Uric acid (mmol/L)
Measured: Baseline and week 12
Renal function - Sodium (mmol/L)
Measured: Baseline and week 12
Renal function - Potassium (mmol/L)
Measured: Baseline and week 12
Renal function - Chloride (mmol/L)
Measured: Baseline and week 12
Liver function - Total protein (g/L)
Measured: Baseline and week 12
Liver function - Albumin (g/L)
Measured: Baseline and week 12
Liver function - Globulin (g/L)
Measured: Baseline and week 12
Liver function - A/G ratio
Measured: Baseline and week 12
Liver function - Total bilirubin (U/L)
Measured: Baseline and week 12
Liver function - Alkaline phosphatase ALP (U/L)
Measured: Baseline and week 12
Liver function - Aspartate aminotransferase AST (U/L)
Measured: Baseline and week 12
Liver function - Alanine aminotransferase ALT (U/L)
Measured: Baseline and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Mar 2025
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Rosli Wan Ishak, Universiti Sains Malaysia
- Investigators
- Wan Rosli Wan Ishak, PhD, Principal investigator, Nutrition and Dietetics Program, School of Health Sciences, Universiti Sains Malaysia Health Campus, Kubang Kerian, Kelantan, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471607
- Sponsor's protocol ID
- USM/JEPeM/KK/23070553
- Other IDs
- R502-KR-ARU001-0000000090-K134
- Acronym
- OBP-T2DM
- Status last verified
- Dec 2025
- First submitted
- 6 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Overripe Banana as an Adjunct to Specific Diabetic Formulas in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07471607
- Acronym / sponsor ID
- OBP-T2DM / USM/JEPeM/KK/23070553
- Conditions
- Type 2 Diabetes, Metabolic Disorders
- Keywords
- overripe banana, functional food, dietary intervention, medical nutrition therapy, randomized controlled trial, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Overripe Banana Powder Formulation | Experimental | Dietary Supplement: Overripe Banana Powder FormulationParticipants 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. |
| Standard Nutritional Formulation | Active comparator | Dietary Supplement: Standard Nutritional FormulationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overripe Banana Powder FormulationA nutritional formulation containing overripe banana powder. Participants consume the supplement once daily throughout the intervention period. | Dietary supplement | Overripe Banana Powder Formulation |
| Standard Nutritional FormulationParticipants consume the standard nutritional formulation once daily during the study period in addition to their usual diet and antidiabetic medication. | Dietary supplement | Standard Nutritional Formulation |
Primary outcome
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.
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.
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.
33 secondary outcomes
Insulin resistance indices - HOMA-IR
Time frame: Baseline and Week 12
Insulin resistance indices - QUICKI
Time frame: Baseline and week 12
Body weight (kg)
Time frame: Baseline and week 12
Body mass index (BMI)
Time frame: Baseline and week 12
Body fat percentage (%)
Time frame: Baseline and week 12
Fat mass (kg)
Time frame: Baseline and week 12
Muscle mass (kg)
Time frame: Baseline and week 12
Visceral fat rating
Time frame: Baseline and week 12
Waist circumference (cm)
Time frame: Baseline and week 12
Hip circumference (cm)
Time frame: Baseline and week 12
Waist-Hip Ratio (WHR)
Time frame: Baseline and week 12
Systolic blood pressure (mmHg)
Time frame: Baseline and week 12
Diastolic blood pressure (mmHg)
Time frame: Baseline and week 12
Total cholesterol (mmol/L)
Time frame: Baseline and week 12
Triglyceride (mmol/L)
Time frame: Baseline and week 12
LDL-cholesterol (mmol/L)
Time frame: Baseline and week 12
HDL-cholesterol (mmol/L)
Time frame: Baseline and week 12
Renal function - Urea (mmol/L)
Time frame: Baseline and week 12
Renal function - Creatinine (µmol/L)
Time frame: Baseline and week 12
Renal function - eGFR (ml/min)
Time frame: Baseline and week 12
Renal function - calcium (mmol/L)
Time frame: Baseline and week 12
Renal function - Uric acid (mmol/L)
Time frame: Baseline and week 12
Renal function - Sodium (mmol/L)
Time frame: Baseline and week 12
Renal function - Potassium (mmol/L)
Time frame: Baseline and week 12
Renal function - Chloride (mmol/L)
Time frame: Baseline and week 12
Liver function - Total protein (g/L)
Time frame: Baseline and week 12
Liver function - Albumin (g/L)
Time frame: Baseline and week 12
Liver function - Globulin (g/L)
Time frame: Baseline and week 12
Liver function - A/G ratio
Time frame: Baseline and week 12
Liver function - Total bilirubin (U/L)
Time frame: Baseline and week 12
Liver function - Alkaline phosphatase ALP (U/L)
Time frame: Baseline and week 12
Liver function - Aspartate aminotransferase AST (U/L)
Time frame: Baseline and week 12
Liver function - Alanine aminotransferase ALT (U/L)
Time frame: Baseline and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available to protect participant confidentiality and comply with institutional and ethical regulations governing clinical research data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Rosli Wan Ishak, PhD principal investigator
Nutrition and Dietetics Program, School of Health Sciences, Universiti Sains Malaysia Health Campus, Kubang Kerian, Kelantan, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overripe Banana Powder Formulation and Standard Nutritional Formulation in people with Type 2 Diabetes and Metabolic Disorders, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (mmol/L) (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.