Diabetes Mellitus
Conditions
Keywords
Blood glucose, diabetes mellitus, HbA1c, red beans, tomatoes
Brief 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. 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
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.
Interventions
COMBINATION_PRODUCTThe 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
Sponsors
University Ngudi Waluyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose | Before intervention and every weeks for 3weeks ( Before intervention, in the first, secon and third weeks) |
| HbA1c meassure | Before intervention and 3 weeks after intervention |
Countries
Indonesia
Outcome results
None listed