Correlation Between Dietary Patterns, Anthropometric Profiles, Genetic Profiles, and Biomarker Levels to Diabetes

NCT07800884 | Completed

• 1 other identifier: 013/KER/FK/04/2025
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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:
• Case group: Balanced healthy diet group, eating 45-65% of calories from carbohydrates, 20-25% of calories from fat, and 10% from protein.
• 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.
• Control group: this group will not receive a diet intervention.

Conditions

Diet Interventions; Diabetes Mellitus

Keywords

diet; diabetes mellitus; genetic; biomarker

Outcome Measures

Primary Outcomes (3)

• HbA1C

  will be presented as a percentage.

  at enrollment and at the end of treatment in week 4

• Fasting glucose

  will be presented in mg/dL

  at enrollment and at the end of treatment in week 4

• Fasting insulin

  will be presented in μU/mL

  at enrollment and at the end of treatment in week 4

Secondary Outcomes (9)

• Body weight

  at enrollment and at the end of treatment in week 4

• Body mass index

  at enrollment and at the end of treatment in week 4

• Cholesterol

  at enrollment and at the end of treatment in week 4

• Low density cholesterol (LDL)

  at enrollment and at the end of treatment in week 4

• High density cholesterol (HDL)

  at enrollment and at the end of treatment in week 4

Study Arms (3)

balanced, healthy diet

EXPERIMENTAL

Balanced healthy diet group, eating 45 - 65% of calories from carbohydrates, 20 - 25% of calories from fat, and 10% from protein

Other: diet intervention

a low-carbohydrate diet group

EXPERIMENTAL

Low-carb diet group, eating pattern with less than 45% of total energy provided by carbohydrates.

Other: diet intervention

Control group

NO INTERVENTION

Subjects in the control group did not receive a special diet, only their dietary intake was monitored.

Interventions

diet intervention OTHER

Subjects in the treatment group will be given a balanced diet or low-carb diet based on the amount of carbohydrates given.

a low-carbohydrate diet group; balanced, healthy diet

Eligibility Criteria

• Age: 18 Years - 59 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Faculty of Medicine Universitas Trisakti

Jakarta, DKI Jakarta, 11440, Indonesia

Location

Related Publications (2)

• Yu EY, Ren Z, Mehrkanoon S, Stehouwer CDA, van Greevenbroek MMJ, Eussen SJPM, Zeegers MP, Wesselius A. Plasma metabolomic profiling of dietary patterns associated with glucose metabolism status: The Maastricht Study. BMC Med. 2022 Nov 21;20(1):450. doi: 10.1186/s12916-022-02653-1.

  PMID: 36414942 RESULT

• Esmaillzadeh A, Kimiagar M, Mehrabi Y, Azadbakht L, Hu FB, Willett WC. Dietary patterns, insulin resistance, and prevalence of the metabolic syndrome in women. Am J Clin Nutr. 2007 Mar;85(3):910-8. doi: 10.1093/ajcn/85.3.910.

  PMID: 17344515 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: September 2, 2026
• Study Start: April 28, 2025
• Primary Completion: July 16, 2025
• Study Completion: September 2, 2025
• Last Updated: September 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)