Healthy Adult ParticipantsNCT07457827
Effect of Low-Carbohydrate Versus Balanced Diets on Anthropometric Blood Pressure, ApoB, and hsCRP in Healthy Adults
A study testing Diet in people with Healthy Adult Participants, run by Trisakti University at 3 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesIndonesia
- Study dates
- 25 Feb 2026to 29 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- a history of type 1 or type 2 diabetes,
- autoimmune disease
- thyroid disease
- major surgery in the past six months,
- ,- eating disorders,
- food allergy
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia3 sites
Faculty of medicine Universitas Trisakti
Jakarta, DKI Jakarta, 11440
Yenny, Doctoral, 08159661333, yennyfarmako@trisakti.ac.id
Faculty of medicine Universitas Trisakti
Jakarta, DKI Jakarta, 11440
Triisakti University
Jakarta, DKI Jakarta, 11440
About this study
Official title: Comparative Evaluation of Low-Carbohydrate and Balanced Diets on Anthropometric and Cardiovascular Risk Markers in Healthy Volunteers: A Single-Blind Randomized Controlled Trial
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
Read the detailed description
In this study, will some questions be recorded in the questioner about sociodemographics and lifestyle habits, and body weight and height will be measured. After that, a 1-tablespoon (5 mL) fasting blood sample be collected 2 times during the study.
- Conditions
- Healthy Adult Participants
- Being tested
- Diet
- Keywords
- Diet, adult, Indonesia, body weight, ApoB, hsCRP
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Comparison of the difference in the composition diet
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 4 weeks
Secondary outcomes (4)
Change from baseline in the mean seated through cuff Systolic pressure at 4 weeks
Systolic blood pressure will be measured in mmHg using an automated upper-arm blood pressure monitor (Omron HEM7120). Measurements will be taken in the seated position after a resting period and recorded at baseline \& week 4.weeks
Measured: Baseline and 4 weeks
Change from baseline in the mean seated Diastolic pressure at 4 weeks
Diastolic blood pressure will be measured in mmHg using an automated upper-arm blood pressure monitor (Omron HEM7120). Measurements will be taken in the seated position after a resting period and recorded at baseline and week 4. weeks
Measured: Baseline & 4 weeks
Change from baseline in Serum Apolipoprotein B (ApoB) concentration at 4 weeks
Venous blood samples will be collected from participants after an overnight fast using serum separator tubes. Serum apolipoprotein B (ApoB) concentration will be measured using an automated immunoturbidimetric assay (Tina-quant® Apolipoprotein B ver.2, Roche Diagnostics, Mannheim, Germany) on a cobas® analyzer. Results will be reported in mg/dL, and measurements will be performed at baseline and week 4.
Measured: Baseline and week 4.
Change from baseline in serum High-Sensitivity C-Reactive Protein (hsCRP) concentration at 4 weeks
Venous blood samples will be collected from participants after an overnight fast using serum separator tubes. High-sensitivity C-reactive protein (hsCRP) concentration will be measured using a particle-enhanced immunoturbidimetric assay (Cardiac CRP High Sensitive, Roche Diagnostics, Mannheim, Germany) on a cobas® analyzer. Results will be reported in mg/L, and measurements will be performed at baseline and week 4.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start25 Feb 2026 (estimated)
- Primary completion29 May 2026 (estimated)
- Study completion29 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trisakti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yenny Farmako, Trisakti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457827
- Sponsor's protocol ID
- 002
- Status last verified
- Mar 2026
- First submitted
- 20 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Low-Carbohydrate and Balanced Diets on Anthropometric and Cardiovascular Risk Markers in Healthy Volunteers: A Single-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07457827
- Acronym / sponsor ID
- 002
- Conditions
- Healthy Adult Participants
- Keywords
- Diet, adult, Indonesia, body weight, ApoB, hsCRP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Trisakti UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (estimated)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 29 May 2026 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
In this study, will some questions be recorded in the questioner about sociodemographics and lifestyle habits, and body weight and height will be measured. After that, a 1-tablespoon (5 mL) fasting blood sample be collected 2 times during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low carbohydrate diet | Experimental | Other: DietThe 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). |
| Balance diet | Experimental | Other: DietBalanced 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). |
| 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- a history of type 1 or type 2 diabetes,
- autoimmune disease
- thyroid disease
- major surgery in the past six months,
- ,- eating disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DietComparison of the difference in the composition diet | Other | Balance diet, Low carbohydrate diet |
Primary outcome
Change from baseline in Body Mass Index (BMI) after 4 weeks
Time frame: baseline and 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.
4 secondary outcomes
Change from baseline in the mean seated through cuff Systolic pressure at 4 weeks
Time frame: Baseline and 4 weeks
Change from baseline in the mean seated Diastolic pressure at 4 weeks
Time frame: Baseline & 4 weeks
Change from baseline in Serum Apolipoprotein B (ApoB) concentration at 4 weeks
Time frame: Baseline and week 4.
Change from baseline in serum High-Sensitivity C-Reactive Protein (hsCRP) concentration at 4 weeks
Time frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be provided upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet in people with Healthy Adult Participants, run by Trisakti University at 3 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yenny Yenny, Doctoral (+628159661333, yennyfarmako@trisakti.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Body Mass Index (BMI) after 4 weeks (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.