RED BEAN AND TOMATO SNACK BAR FORMULATIONS AS A HEALTHY SNACK FOR DIABETES MELLITUS PATIENTS

November 19, 2025 updated by: Ummu Muntamah, University Ngudi Waluyo

DEVELOPMENT OF "GLYCEMIC CONTROL BAR WITH BEANS AND TOMATO FOR DIABETIC EATING" (GLYCOBITE) SNACK BAR FORMULATIONS AS A HEALTHY SNACK FOR DIABETES MELLITUS PATIENTS

The goal of this clinical trial is to develop a "GlycoBite" snack bar formulation combination of red beans and tomatoes, and to assess its acceptability, nutritional content, and effectiveness on blood glucose levels in diabetic patients. The main questions it aims to answer are:

  1. Dose snack bar formulation combination of red beans and tomatoes as a potensial healthy snack for diabetic patients?
  2. Does snack bar formulation combination of red beans and tomatoes improve glycemic control
  3. Does snack bar formulation combination of red beans and tomatoes lower blood glucose

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Researchers will compare GlycoBite (red beans and tomato combine) snack bar to commercial snack bar to see if GlycoBite works to control blood glucose

Participants will:

  1. Take 40 grams of GlycoBite or commercial snack bar every day for 3 weeks
  2. Weekly fasting blood glucose monitoring and evaluations were carried out.
  3. Monitoring glycemic control ( HbA1c Levels) before and after intervention.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50513
        • Semarang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Type 2 DM patients
  2. No medication therapy modifications during the intervention; and 4) no

Exclusion Criteria:

  1. Other extreme diets
  2. Severe stress or acute infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Patients in the control group consumed two packs of commercial snack bars, each weighing 20 grams every day. The intervention was conducted for 3 weeks.
Combination product: The GlycoBite snack bar formula created is to combine tomatoes and red beans in a ratio of 60% and 40% respectively. Participants consuming 40 grams of "GlycoBite" snack bars daily
Participants consuming 40 grams of "GlycoBite" snack bars daily for 3 weeks
Experimental: Intervention group
Participants consuming 40 grams of "GlycoBite" snack bars daily for 3 weeks.
Combination product: The GlycoBite snack bar formula created is to combine tomatoes and red beans in a ratio of 60% and 40% respectively. Participants consuming 40 grams of "GlycoBite" snack bars daily
Participants consuming 40 grams of "GlycoBite" snack bars daily for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fasting blood glucose
Time Frame: Before intervention and every weeks for 3weeks ( Before intervention, in the first, secon and third weeks)
Before intervention and every weeks for 3weeks ( Before intervention, in the first, secon and third weeks)
HbA1c meassure
Time Frame: Before intervention and 3 weeks after intervention
Before intervention and 3 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ngudi Waluyo

Investigators

  • Principal Investigator: Ummu Muntamah, PhD, Ngudi Waluyo University
  • Study Chair: Medina Sianturi, PhD, Stikes E;;isabeth Semarang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2025

Primary Completion (Estimated)

November 20, 2025

Study Completion (Estimated)

November 22, 2025

Study Registration Dates

First Submitted

November 19, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 28, 2025

Study Record Updates

Last Update Posted (Actual)

November 28, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NgudiWaluyoUniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe