An interventional study of Diet in Healthy Adult Participants, sponsored by Trisakti University. Not yet recruiting at 3 sites in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Trisakti University · Not applicable, Interventional, and Prevention
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:
Participants will:
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.
657 studies on the registry are indexed under Body Weight; 76 are open to participants now.
This study's planned enrollment of 135 is above the median of 71 across 500 interventional studies indexed under Body Weight.
Browse Body Weight studies →Trisakti University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
major surgery in the past six months,
,- eating disorders,
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 (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).
Comparison of the difference in the composition diet
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.
Time frame: baseline and 4 weeks
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 4 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Data will be provided upon request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 6 month after publish
Access criteria: principle investigator that need access the data can contact contact me through
Data sharing details ↗ · trisakti.ac.id
Start is estimated for Feb 2026; primary completion for May 2026, 3 months later.
Of 206 non-industry interventional studies with no phase under Body Weight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 40. This study's planned 3 months is below that.
Counting every sponsor, half of 226 studies reached it within 18 months; a quarter within 7 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Trisakti University