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Diabetes MellitusNCT07255170

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

A study testing 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 in people with Diabetes Mellitus, run by University Ngudi Waluyo at 1 site in Indonesia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Diabetes Mellitus
What is being tested?
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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteIndonesia
Study dates
15 Aug 2025to 22 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Other extreme diets
  • Severe stress or acute infection

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Semarang

    Semarang, Central Java, 50513

Other trials in Indonesia

About this study

Official title: 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
Read the 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.
Being tested
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
Keywords
Blood glucose, diabetes mellitus, HbA1c, red beans, tomatoes
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 dailyCombination product

    Participants consuming 40 grams of "GlycoBite" snack bars daily for 3 weeks

Study groups in NCT07255170
Study groupRoleWhat they receive
control groupActive comparatorPatients in the control group consumed two packs of commercial snack bars, each weighing 20 grams every day. The intervention was conducted for 3 weeks.
Receives: 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
Intervention groupExperimentalParticipants consuming 40 grams of "GlycoBite" snack bars daily for 3 weeks.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting blood glucose

    Measured: Before intervention and every weeks for 3weeks ( Before intervention, in the first, secon and third weeks)

  2. HbA1c meassure

    Measured: Before intervention and 3 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start15 Aug 2025
  3. Primary completion20 Nov 2025 (estimated)
  4. Study completion22 Nov 2025 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study comprise 100 participants who were randomly allocated to two groups. The GlycoBite group, consisting of 50 participants consuming 40 grams of "GlycoBite" snack bars daily and the control group consumed two packs of commercial snack bars, each weighing 20 grams. The intervention was conducted for 3 weeks. Weekly monitoring and evaluations were carried out. Interviews were done as part of the monitoring and evaluation procedure to find out 1) how compliant the participants were with snack bar consumption, 2) whether their activity changed, and 3) whether they had any complaints while eating. In the beginning, all participants had comprehensive history taking and clinical evaluation. Blood specimens were obtained following a 12-hour fasting period to assess the subsequent parameters at baseline and after treatment to evaluate blood glucose levels and HbA1c levels
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255170
Sponsor's protocol ID
NgudiWaluyoUniversity
Status last verified
Nov 2025
First submitted
19 Nov 2025
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Leh HE, Mohd Sopian M, Abu Bakar MH, Lee LK. The role of lycopene for the amelioration of glycaemic status and peripheral antioxidant capacity among the Type II diabetes mellitus patients: a case-control study. Ann Med. 2021 Dec;53(1):1059-1065. doi: 10.1080/07853890.2021.1943515.

    PubMed 34180336

  • Has IM, Vodnar DC, Bungau AF, Tarce AG, Tit DM, Teleky BE. Enhanced Elderberry Snack Bars: A Sensory, Nutritional, and Rheological Evaluation. Foods. 2023 Sep 23;12(19):3544. doi: 10.3390/foods12193544.

    PubMed 37835197

  • Dimopoulou M, Vareltzis P, Floros S, Androutsos O, Bargiota A, Gortzi O. Development of a Functional Acceptable Diabetic and Plant-Based Snack Bar Using Mushroom (Coprinus comatus) Powder. Foods. 2023 Jul 14;12(14):2702. doi: 10.3390/foods12142702.

    PubMed 37509794

  • Md Isa Z, Ismail NH, Mohd Tamil A, Jaafar MH, Ismail R, Mohamed Noor Khan NA, Mat Nasir N, Ab Razak NH, Zainol Abidin N, Yusof KH. Pattern of macronutrients intake among type-2 diabetes mellitus (T2DM) patients in Malaysia. BMC Nutr. 2023 Jan 30;9(1):21. doi: 10.1186/s40795-022-00648-y.

    PubMed 36717873

  • Diabetes Canada Clinical Practice Guidelines Expert Committee; Sievenpiper JL, Chan CB, Dworatzek PD, Freeze C, Williams SL. Nutrition Therapy. Can J Diabetes. 2018 Apr;42 Suppl 1:S64-S79. doi: 10.1016/j.jcjd.2017.10.009. No abstract available.

    PubMed 29650114

  • Kabiruyunusa A, Abdullahi N, Aliyu A. Kinetics of the thermal degradation of lycopene in tomatoes. Croat J Food Sci Technol 2020;12:84-9. https://doi.org/10.17508/cjfst.2020.12.1.11.

  • Zaddana C, Nurmala S, Oktaviyanti T. Snack Bar Berbahan Dasar Ubi Ungu dan Kacang Merah sebagai Alternatif Selingan untuk Penderita Diabetes Mellitus Snack Bar Based on Purple Sweet Potato and Red Bean as an Alternative Snack for Diabetes Mellitus. Amerta Nutr 2021;1:260-75. https://doi.org/10.20473/amnt.v5i3.2021.

  • Capanoglu E, Beekwilder J, Boyacioglu D, De Vos RC, Hall RD. The effect of industrial food processing on potentially health-beneficial tomato antioxidants. Crit Rev Food Sci Nutr. 2010 Nov;50(10):919-30. doi: 10.1080/10408390903001503.

    PubMed 21108072

  • Li M, Wang B, Lv W, Lin R, Zhao D. Characterization of pre-gelatinized kidney bean (Phaseolus vulgaris L.) produced using microwave hot-air flow rolling drying technique. Lwt 2022;154:112673. https://doi.org/10.1016/j.lwt.2021.112673.

  • Ali MY, Sina AA, Khandker SS, Neesa L, Tanvir EM, Kabir A, Khalil MI, Gan SH. Nutritional Composition and Bioactive Compounds in Tomatoes and Their Impact on Human Health and Disease: A Review. Foods. 2020 Dec 26;10(1):45. doi: 10.3390/foods10010045.

    PubMed 33375293

  • Sianturi M, Susilaningsih N, Nugroho H, Suryani M. Lycopene Improves the Metformin Effects on Blood Glucose and Neutrophil Counts in Type 2 Diabetic Rats. Indones J Med Lab Sci Technol 2023;5:80-9. https://doi.org/10.33086/ijmlst.v5i1.3865.

  • Leh HE, Lee LK. Lycopene: A Potent Antioxidant for the Amelioration of Type II Diabetes Mellitus. Molecules. 2022 Apr 4;27(7):2335. doi: 10.3390/molecules27072335.

    PubMed 35408734

  • Khan UM, Sevindik M, Zarrabi A, Nami M, Ozdemir B, Kaplan DN, Selamoglu Z, Hasan M, Kumar M, Alshehri MM, Sharifi-Rad J. Lycopene: Food Sources, Biological Activities, and Human Health Benefits. Oxid Med Cell Longev. 2021 Nov 19;2021:2713511. doi: 10.1155/2021/2713511. eCollection 2021.

    PubMed 34840666

  • Zhang Y, Bai Z, Xi X, Yang K, Yue C, Li P, Zhang K, Gao H, Guo J, Luo D. Influence of long-chain inulin phosphate monoester on structural and antidiabetic characteristics of red kidney bean steamed bread. Int J Biol Macromol. 2025 May;308(Pt 3):141965. doi: 10.1016/j.ijbiomac.2025.141965. Epub 2025 Mar 17.

    PubMed 40101828

  • Xu S, Qin L, Mazhar M, Zhu Y. Functional components profile and glycemic index of kidney beans. Front Nutr. 2022 Nov 2;9:1044427. doi: 10.3389/fnut.2022.1044427. eCollection 2022.

    PubMed 36407530

Questions about this trial

What is this clinical trial studying?

A study testing 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 in people with Diabetes Mellitus, run by University Ngudi Waluyo at 1 site in Indonesia.

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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2025. 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 Indonesia. 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: Before intervention and every weeks for 3weeks ( Before intervention, in the first, secon and third weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07255170, which also lists 26 linked publications.

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 28 Nov 2025.

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