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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Other | Comparison of the difference in the composition diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yenny Yenny, Doctoral | Contact | +628159661333 | yennyfarmako@trisakti.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine Universitas Trisakti | Jakarta | DKI Jakarta | 11440 | Indonesia |
Data will be provided upon request
6 month after publish
principle investigator that need access the data can contact contact me through
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 1, 2025 | Mar 4, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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 |
| 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. | 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. | Baseline and 4 weeks |
| Faculty of medicine Universitas Trisakti | Jakarta | DKI Jakarta | 11440 | Indonesia |
| Triisakti University | Jakarta | DKI Jakarta | 11440 | Indonesia |