The Mediterranean Diet Based on Local Foods for Obese Patients: A Study of Anthropometric Parameters, Inflammatory Markers, and Gut Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The implementation of a locally adapted Mediterranean has the potential to improve anthropometric outcomes profiles in obese.
研究概览
简要总结
The goal of this clinical trial is to examine the efficacy of a Mediterranean diet based on local Indonesian foods on alterations in gut microbiota, body composition, and metabolic biomarkers in obese subjects. The main questions it aims to answer are:
Dose Mediterranean diet modification based on local food ingredients can result in greater weight loss, greater reductions in inflammatory markers, improve gut microbiota diversity compared to a balanced low-calorie diet in obese patients?
Researchers will compare Mediterranean diet modification based on local food to low calorie diet.
Participant will:
- Participants received a low-calorie diet of approximately 1.500 kcal/day according to their randomized group assignments, consisting of breakfast, lunch, dinner, and snacks. Both groups will receive dietary education and physical activity guidance tailored to their weight loss needs.
- Participants were instructed to complete a food intake record and report their consumption to the researchers using intake forms and photographs of the food packaging. Weekly meetings were held via Zoom to evaluate dietary compliance.
- Blood samples and fecal specimens were collected at baseline (week 0) and at week 4 of 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
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who were obese, as defined by a BMI of at least
- •Aged 18-50 years
- •Subjects with a non-shift work schedule
- •Willing to follow the research procedures and sign the informed consent form.
排除标准
- •Subjects with a history of type 2 diabetes, kidney disease, liver disease, or thyroid disorders, as indicated by medical history or medical records.
- •Contraindications for the MF-BIA examination include the use of pacemakers or implants and a history of amputation.
- •Pregnant or within 40 days of childbirth
- •Adults with edema
- •Taking medications with hyperglycemic effects, such as beta-blockers, thiazides, corticosteroids, calcineurin inhibitors, anti-dyslipidemic medications (e.g., statins, fibrates, niacin, and bile acid sequestrants), or antibiotics.
- •History of food allergies
研究组 & 干预措施
Low calorie diet
In the control group, Participants received a low calorie diet providing approximately 1,500 kcal/day, the diet provided 50-54% carbohydrates, 25-30% fat (SFA < 12%, MUFA 8-12%, PUFA 5-8%), and 19-20% protein.
干预措施: Locally Adapted Mediterranean Diet (Other)
Locally Adapted Mediterranean Diet
In the interventional group, participants received a locally adapted Mediterranean diet providing approximately 1,500 kcal/day, with a macronutrient distribution of 50% carbohydrates, 30-34% fat (saturated fatty acids ≤ 8%, monounsaturated fatty acids 15-20%, polyunsaturated fatty acids 5-10%), and 17-20% protein.
干预措施: Low calorie diet (Other)
结局指标
主要结局
The implementation of a locally adapted Mediterranean has the potential to improve anthropometric outcomes profiles in obese.
时间窗: The data were collected at baseline (week 0) and at week 4 of the study.
Title of the research is The Mediterranean Diet Based on Local Foods for Obese Patients: A Study of Anthropometric Parameters, Inflammatory Markers, and Gut Microbiota. Based on PRS review of each outcome the findings are described as follows: Anthropometric outcomes (ratio data scale): 1. Body mass index (BMI) will be calculated from weight (kilograms) and height (meters). Divide weight in kilograms (kilograms) by height in meters squared (meters²) expressed as kg/m². 2. Waist-to-hip ratio (WHR) is calculated by dividing waist circumference (centimeters) by hip circumference (centimeters) and expressed as cm. (WHR = Waist / Hip)
次要结局
- To determine the characteristics of the research subjects based on age.(The data were collected at baseline (week 0))
- To determine the characteristics of the research subjects based on underlying disease.(The data were collected at baseline (week 0))
- To determine the characteristics of the research subjects based on nutritional status.(The data were collected at baseline (week 0))
- To determine the characteristics of the research subjects based on body composition.(The data were collected at baseline (week 0)])
- To determine the characteristics of the research subjects based on intake patterns.(The data were collected at baseline (week 0))
- To determine the characteristics of the research subjects based on physical activity.(The data were collected at baseline (week 0))
- To determine the energy, protein, fat, and carbohydrate intake of research subjects before and after diet administration.(the data were collected at baseline (week 0) and at week 4 of the study.)
- To determine the differences in the mean anthropometry of the research subjects in each group.(The data were collected at baseline (week 0) and at week 4 of the study.)
- To determine the differences the mean in nutritional status of the research subjects in each group.(The data were collected at baseline (week 0) and at week 4 of the study.)
- To determine the differences in the mean body composition of the research subjects in each group.(The data were collected at baseline (week 0) and at week 4 of the study.)
- To determine changes and mean in IL-6 levels in research subjects before and after diet administration.(the data were collected at baseline (week 0) and at week 4 of the study.)
- To determine changes and mean in I-FABP levels in research subjects before and after diet administration.(the data were collected at baseline (week 0) and at week 4 of the study.)
- To determine changes and mean in TyG index levels in research subjects before and after diet administration.(the data were collected at baseline (week 0) and at week 4 of the study.)
- To determine the effect of a locally adapted Mediterranean diet (intervention) and low calorie diet (control) on improving gut microbiota diversity in obese patients.(the data were collected at baseline (week 0) and at week 4 of the study.)
- To determine the effect of a locally adapted Mediterranean diet (intervention) and low calorie diet (control) on improving metabolomic profile in obese patients.(the data were collected at baseline (week 0) and at week 4 of the study.)
研究者
Diyah Eka Andayani
Principle Investigator, Clinical Nutrition Specialist
Indonesia University