Comparative Evaluation of Low-Carbohydrate and Balanced Diets on Anthropometric and Cardiovascular Risk Markers in Healthy Volunteers: A Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Change from baseline in Body Mass Index (BMI) after 4 weeks
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Low carbohydrate diet
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).
干预措施: Diet (Other)
Balance 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).
干预措施: Diet (Other)
Control group
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).
结局指标
主要结局
Change from baseline in Body Mass Index (BMI) after 4 weeks
时间窗: 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.
次要结局
- 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)
研究者
Yenny Farmako
Principal investigator
Trisakti University