Faculty of Medicine Universitas Trisakti
Jakarta, DKI Jakarta, 11440, Indonesia
NCT Number: NCT07800884
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.
Looking for future studies?
Notify Me18 year–59 year
All sexes
Interventional
Not applicable
Jakarta, DKI Jakarta, 11440, Indonesia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects in the treatment group will be given a balanced diet or low-carb diet based on the amount of carbohydrates given.
Time frame: at enrollment and at the end of treatment in week 4
will be presented as a percentage.
Time frame: at enrollment and at the end of treatment in week 4
will be presented in mg/dL
Time frame: at enrollment and at the end of treatment in week 4
will be presented in μU/mL
Time frame: at enrollment and at the end of treatment in week 4
will be measured in kg
Time frame: at enrollment and at the end of treatment in week 4
is expressed in kg/m^2
Time frame: at enrollment and at the end of treatment in week 4
is expressed in mg/dL
Time frame: at enrollment and at the end of treatment in week 4
is expressed in mg/dL
Time frame: at enrollment and at the end of treatment in week 4
is expressed in mg/dL
Time frame: at enrollment and at the end of treatment in week 4
is expressed in mg/dL
Time frame: at enrollment and at the end of treatment in week 4
is expressed in U/L
Time frame: at enrollment and at the end of treatment in week 4
is expressed in U/L
Time frame: at enrollment and at the end of treatment in week 4
is expressed in mg/dL
Indonesia University
Other
Elucidating the Correlation Between Dietary Patterns, Anthropometric Measurements, Genetic Profiles, and Biomarker Levels Related to Diabetes
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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