Healthy Adult Participants
Conditions
Keywords
Diet, adult, Indonesia, body weight, ApoB, hsCRP
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
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.
Interventions
OTHERDiet
Comparison of the difference in the composition diet
Sponsors
Trisakti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Body Mass Index (BMI) after 4 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the mean seated through cuff Systolic pressure at 4 weeks | Baseline and 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 |
| Change from baseline in the mean seated Diastolic pressure at 4 weeks | Baseline & 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 |
| Change from baseline in Serum Apolipoprotein B (ApoB) concentration at 4 weeks | Baseline and week 4. | 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. |
| Change from baseline in serum High-Sensitivity C-Reactive Protein (hsCRP) concentration at 4 weeks | Baseline and 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. |
Countries
Indonesia
Contacts
CONTACTYenny Yenny, Doctoral
Outcome results
None listed