Effect of Low-Carbohydrate Versus Balanced Diets on Anthropometric Blood Pressure, ApoB, and hsCRP in Healthy Adults

NCT07457827 | Not Yet Recruiting DMC

• 1 other identifier: 002
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to explore the effect of a low-carbohydrate diet and a balanced diet. The main questions it aims to answer are:

• Does a 4-week diet intervention improve anthropometric and cardiovascular parameters?
• What diet is more effective in promoting weight loss and improving cardiovascular parameters? Researchers will compare a low-carbohydrate diet and a balanced diet with control group. Participants will:
• Take the intervention diet or control diet for 4 weeks
• will submit food records three times a week
• Visit the study location 2 times for check up and test

Conditions

Healthy Adult Participants

Keywords

Diet; adult; Indonesia; body weight; ApoB; hsCRP

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Body Mass Index (BMI) after 4 weeks

  Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters (kg/m²). Body weight will be measured using a Seca 876 scale (Hamburg, Germany) with an accuracy of 0.1 kg, and height will be measured using a Seca 213 stadiometer (Hamburg, Germany) with an accuracy of 0.1 cm. Measurements will be performed at baseline and at the end of the intervention.

  baseline and 4 weeks

Secondary Outcomes (4)

• Change from baseline in the mean seated through cuff Systolic pressure at 4 weeks

  Baseline and 4 weeks

• Change from baseline in the mean seated Diastolic pressure at 4 weeks

  Baseline & 4 weeks

• Change from baseline in Serum Apolipoprotein B (ApoB) concentration at 4 weeks

  Baseline and week 4.

• Change from baseline in serum High-Sensitivity C-Reactive Protein (hsCRP) concentration at 4 weeks

  Baseline and 4 weeks

Study Arms (3)

Low carbohydrate diet

EXPERIMENTAL

The low-carbohydrate diet group will receive a dietary intervention focused on a diet with \<45% of total energy from carbohydrates. Participants will receiving three meals and two snacks for 20 days (on weekdays for four weeks). During the study period, participants will submit food records three times a week (two days on weekdays and one day on weekends).

Other: Diet

Balance diet

EXPERIMENTAL

Balanced diet group will receive a dietary intervention consisting of 45-65% of total calories from carbohydrates, 20-25% from fat, and 10% from protein. Participants will receiving three meals and two snacks for 20 days (on weekdays for four weeks). During the study period, participants will submit food records three times a week (two days on weekdays and one day on weekends).

Other: Diet

Control group

NO INTERVENTION

Control group (without dietary intervention), will maintain their usual diet. During the study period, participants will submit food records three times a week (two days on weekdays and one day on weekends).

Interventions

Diet OTHER

Comparison of the difference in the composition diet

Balance diet; Low carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age 18-59 years old
• ability to follow the prescribed meal plan and examination schedule during the study
• willing to participate in this study by signing informed consent

You may not qualify if:

• a history of type 1 or type 2 diabetes,
• autoimmune disease
• thyroid disease
• major surgery in the past six months,
• ,- eating disorders,
• food allergy
• participation in other clinical trials
• impaired kidney function with serum creatinine ≥1.5 mg/dL
• abnormal liver function with alanine aminotransferase and aspartate aminotransferase levels exceeding threefold.

Sponsors & Collaborators

• Trisakti University: lead

Study Sites (3)

Faculty of medicine Universitas Trisakti

Jakarta, DKI Jakarta, 11440, Indonesia

Location

Faculty of medicine Universitas Trisakti

Jakarta, DKI Jakarta, 11440, Indonesia

Location

Triisakti University

Jakarta, DKI Jakarta, 11440, Indonesia

Location

MeSH Terms

Conditions

Body Weight

Interventions

Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Yenny Yenny, Doctoral

CONTACT

+628159661333; yennyfarmako@trisakti.ac.id

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: February 20, 2026
• First Posted: March 9, 2026
• Study Start: February 25, 2026
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 6 month after publish
• Access Criteria: principle investigator that need access the data can contact contact me through

Locations

ID (3)