The Effect of a Low-Calorie Diet Rich in Medium-Chain Triglycerides Based on Traditional Minangkabau Foods on Lipid Profile, Leptin Levels, and DNA Methylation of the Leptin Gene Promoter in Individuals With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from baseline in body mass index (BMI).
研究概览
简要总结
This study aims to investigate the effect of a low-calorie diet rich in medium-chain triglycerides (MCTs) based on traditional Minangkabau foods on metabolic biomarkers in individuals with obesity. The traditional Minangkabau foods used in this study consist primarily of coconut milk-based dishes, which contain coconut oil as a natural source of MCTs. The metabolic biomarkers assessed include body mass index (BMI), waist circumference, systolic and diastolic blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter. Based on these metabolic biomarker measurements, participants will be classified into metabolic obesity phenotypes, namely metabolically healthy obesity (MHO) and metabolically unhealthy obesity (MUHO). The researchers hypothesize that the provision of a low-calorie, MCT-rich diet based on traditional Minangkabau foods will have a significant effect on metabolic biomarkers and metabolic status in individuals with obesity.
详细描述
This study was conducted within the Faculty of Medicine and the Faculty of Public Health at Andalas University, Padang, and received ethical approval from the Research Ethics Committee of the Faculty of Medicine, Andalas University. The study population consisted of educational staff with a body mass index (BMI) greater than 25 kg/m². Study participants were educational staff who agreed to participate and provided written informed consent. A total of 40 participants were included in the study, comprising 20 participants in the intervention group and 20 participants in the control group.
The study was conducted over a period of 12 weeks (90 days). One week prior to the intervention, dietary intake was assessed using the 24-hour food recall method. Anthropometric measurements were performed using calibrated instruments by trained personnel.
Participants in both the intervention and control groups underwent a one-week pre-intervention period (baseline period, from day -6 to day 0), during which they were instructed not to consume any supplements. Anthropometric measurements, blood pressure, body fat percentage, fasting blood glucose levels, lipid profile, leptin concentrations, and DNA methylation of the leptin gene promoter were assessed on day 0 and day 90.
Dietary intake data obtained from the 24-hour food recall interviews were analyzed using the NutriSurvey 2005 software. The dietary intervention was designed to provide an energy deficit of 500-600 kcal compared with participants' habitual daily intake. The diet was based on traditional Minangkabau foods.
Participants in the intervention group were provided with daily menu plans for breakfast, lunch, and dinner. The dietary intervention was prepared independently by participants in accordance with the dietary guidelines and menus provided. In contrast, the control group followed a standard nutritionally balanced diet according to individual requirements. Participants were instructed to record their daily food intake in a food diary, which was collected and evaluated twice weekly (on weekdays and weekends). In addition, the research team monitored and motivated all participants through WhatsApp groups. Data analysis was performed using SPSS software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Administrative staff of the Faculty of Medicine and the Faculty of Public Health, Andalas University, Padang, with obesity defined as a body mass index (BMI) ≥ 25 kg/m².
- •Willing to participate in the study by providing written informed consent.
- •Participants with obesity classified as Metabolically Unhealthy Obese (MUHO)
排除标准
- •Did not come and could not be found at the time of research data collection
- •Unable to follow the dietary arrangements as set
- •Taking anti-diabetic or anti-lipid drugs
- •Use of contraceptives or hormonal drugs
- •In the treatment of radiotherapy or chemotherapyi
- •Participants with obesity classified as Metabolically Healthy Obese (MHO)
研究组 & 干预措施
Control group (standard nutritionally balanced diet)
Standard Nutritionally Balanced Diet Participants in the control group received a standard nutritionally balanced diet without specific emphasis on MCT content. This diet was not designed to induce an energy deficit and was instead tailored to participants' usual daily dietary habits and energy requirements. Assessments were conducted before and after the study period.
Intervention group (low-calorie diet rich in medium-chain triglycerides [MCTs] based on traditiona
Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods Participants in the intervention group received a nutritionally balanced low-calorie diet rich in medium-chain triglycerides (MCTs) derived from traditional Minangkabau foods. The dietary intervention was designed to provide an energy deficit of 500-600 kcal compared with participants' habitual daily intake. Assessments were conducted before and after the intervention period.
干预措施: Low-Calorie Diet Rich in Medium-Chain Triglycerides (MCTs) Based on Traditional Minangkabau Foods (Other)
结局指标
主要结局
Change from baseline in body mass index (BMI).
时间窗: After 12 weeks
BMI is calculated as body weight in kilograms divided by the square of height in meters (kg/m²).
Change from baseline in waist circumference.
时间窗: After 12 weeks
Waist circumference is measured around the abdomen at the level of the umbilicus.
Change from baseline in body fat percentage
时间窗: After 12 weeks
Body fat percentage is assessed using bioelectrical impedance analysis (BIA).
Change from baseline in systolic and diastolic blood pressure
时间窗: After 12 weeks
Blood pressure is measured using a digital tensimeter.
Change from baseline in fasting blood glucose levels.
时间窗: After 12 weeks
Fasting blood glucose levels are measured using a clinical chemistry analyzer.
Change from baseline in lipid profile.
时间窗: After 12 weeks
The lipid profile includes total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, and low-density lipoprotein (LDL) cholesterol. Measurements are performed using a clinical chemistry analyzer (photometer).
Change from baseline in serum leptin.
时间窗: After 12 weeks
Serum leptin concentrations are measured using appropriate laboratory methods (ELISA).
Change from baseline in DNA methylation of the leptin gene promoter.
时间窗: After 12 weeks
DNA methylation status of the leptin gene promoter is assessed using MSP (Methylation-Specific PCR).
次要结局
- Change in metabolic status.(After 12 weeks)
研究者
Nola Vita Sari
Bachelor of Nutrition
Andalas University