Diabetes Mellitus, Diet Interventions
Conditions
Keywords
diet, diabetes mellitus, genetic, biomarker
Brief summary
The goal of this clinical trial is to explore the correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in diabetes in healthy adults. The primary objective is to examine the correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in the context of diabetes. Secondary Objectives: * To examine the relationship between the diabetes parameters, dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels in the intervention group and control group following a month-long diet. * To examine the correlation between subjects' characteristics (age, sex, educational background, ethnic background, and economic status) and diabetes parameters * To examine the correlation between subjects' life habits (exercise, smoking, sleeping) and diabetes parameters * To examine the compliance of subjects to study intervention * To examine the progression of anthropometric measurements during the study period * The process involves identifying changes between markers related to the development of diabetes. * To develop a risk prediction of diabetes based on dietary intake and health indicators. Hypothesis: There was a correlation between dietary patterns, anthropometric measurements, genetic profiles, and biomarker levels and their impact on glucose levels and other relevant biomarkers in the context of diabetes. Participants: One hundred fifty individuals will participate in the study, providing substantial data for analysis. Participants will undergo dietary interventions and biomarker testing (continuous and checkpoint) to establish baseline data for health indicators, specifically diabetes. Three groups of participants will be recruited: 1. Case group: Balanced healthy diet group, eating 45-65% of calories from carbohydrates, 20-25% of calories from fat, and 10% from protein. 2. Low-carb diet group: an eating pattern with \<45% of total energy provided by carbohydrates. This group will undergo two different meal diets to see changes in blood biomarkers due to specific diet variations. 3. Control group: this group will not receive a diet intervention.
Detailed description
Subject recruitment starts by sharing information across various platforms, such as WhatsApp groups and brochures distributed on the Trisakti University campus. Recruitment is open to students, faculty members, their families, and residents living near Trisakti University. Subsequently, an online meeting is held to outline the participation requirements, research stages, timeline, potential benefits, and possible side effects. A Google Form is then distributed for completion by meeting attendees who are genuinely interested in participating. Concurrently with subject recruitment, the eligibility of the catering service responsible for preparing the meals-specifically for the balanced diet and low-carb diet groups-is assessed. The dietary regimen covers three main meals and two snacks daily. Meals are delivered three times a day: the first and second deliveries (covering breakfast, lunch, and morning/afternoon snacks) are made to the Trisakti University campus, while the third delivery is made directly to each subject's home. Deliveries take place on weekdays (Monday through Friday), with no deliveries on Saturdays or Sundays. A dietitian monitors dietary intake two to three times per week. Before the study begins, dietary education on balanced nutrition is provided to the balanced diet and control groups; the low-carb group also receives specific dietary education. This education ensures that subjects can maintain their prescribed diets on Saturdays and Sundays when no meals are delivered. At the beginning of the study, all participants underwent fasting blood glucose testing to exclude those with fasting blood glucose levels \>100 mg/dL. Subsequently, baseline laboratory tests were performed, and the experimental study commenced. The study was conducted over four weeks. Caloric intake is determined on an individual basis. A dietitian records and documents meal delivery daily. At the conclusion of the study, a meeting will be held featuring a geneticist to explain the genetic test results, an internist to interpret the laboratory findings, and a nutrition specialist to provide dietary guidance based on the study results, followed by a health discussion related to the research topic.
Interventions
OTHERdiet intervention
Subjects in the treatment group will be given a balanced diet or low-carb diet based on the amount of carbohydrates given.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18-59 years * Participants must provide informed consent to participate in the study, which include dietary tracking, biometric testing, and adherence to the intervention program. * Participants must be available for the full duration of the study (one months) and able to comply with the scheduled meal plans and testing appointments.
Exclusion criteria
* Individuals with history of type 1 and 2 diabetes, autoimmune, thyroid disease, which may affect carbohydrate metabolism. * Individuals who have experienced major surgery in the past six months, as it might impact carbohydrate metabolism and the body's reaction to dietary modifications. * Individuals with eating disorders, given the potential risks associated with dietary changes and the focus on food intake and biometrics. * Individuals with allergies or intolerances to the ingredients used in the study's meal plans to prevent adverse health effects and ensure participant safety. * Individuals currently participating in other clinical trials that could influence the outcomes of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C | at enrollment and at the end of treatment in week 4 | will be presented as a percentage. |
| Fasting glucose | at enrollment and at the end of treatment in week 4 | will be presented in mg/dL |
| Fasting insulin | at enrollment and at the end of treatment in week 4 | will be presented in μU/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | at enrollment and at the end of treatment in week 4 | will be measured in kg |
| Body mass index | at enrollment and at the end of treatment in week 4 | is expressed in kg/m\^2 |
| Cholesterol | at enrollment and at the end of treatment in week 4 | is expressed in mg/dL |
| Low density cholesterol (LDL) | at enrollment and at the end of treatment in week 4 | is expressed in mg/dL |
| High density cholesterol (HDL) | at enrollment and at the end of treatment in week 4 | is expressed in mg/dL |
| Total bilirubin | at enrollment and at the end of treatment in week 4 | is expressed in mg/dL |
| Trigliserida | at enrollment and at the end of treatment in week 4 | is expressed in mg/dL |
| Alanine Aminotransferase | at enrollment and at the end of treatment in week 4 | is expressed in U/L |
| Aspartate Aminotransferase | at enrollment and at the end of treatment in week 4 | is expressed in U/L |
Countries
Indonesia
Outcome results
None listed