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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54
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.
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.
Department of Nutrition, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
The implementation of a locally adapted Mediterranean has the potential to improve anthropometric outcomes profiles in obese.
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)
Time frame: The data were collected at baseline (week 0) and at week 4 of the study.
To determine the characteristics of the research subjects based on age.
Age was recorded in years.
Time frame: The data were collected at baseline (week 0)
To determine the characteristics of the research subjects based on underlying disease.
Information on underlying diseases was collected using a structured questionnaire.
Time frame: The data were collected at baseline (week 0)
To determine the characteristics of the research subjects based on nutritional status.
Subjects' nutritional status was assessed and categorized based on body mass index (BMI) as obesity (≥27.0).
Time frame: The data were collected at baseline (week 0)
To determine the characteristics of the research subjects based on body composition.
Body composition was assessed using multi-frequency bioelectrical impedance analysis (MF-BIA) and included measurements of BMI, fat mass (in percentage), fat mass index (in percentage), energy stored in body (in Kilocalorie), Resting Energy Expenditure (in Kilocalorie), Total Energy Expenditure (in Kilocalorie), fat free mass (in percentage), Fat Free Mass Index, skeletal muscle mass (in percentage), Total Body Water (in percentage), Extra Cellular Water (in percentage), Bioelectrical Impedance Vector Analysis, visceral fat (in grams), dan phase angle.
Time frame: The data were collected at baseline (week 0)]
To determine the characteristics of the research subjects based on intake patterns.
Intake patterns were assessed using a questionnaire or food recall and reported in kcal.
Time frame: The data were collected at baseline (week 0)
To determine the characteristics of the research subjects based on physical activity.
Global Physical Activity Questionnaire (GPAQ) to measure physical activity levels and sedentary behavior (Low: \< 600 MET-minutes/week, Moderate: 600-3000 MET-minutes/week, High:≥ 3,000 MET-minutes/week)
Time frame: 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.
Energy (Kilocalorie), protein (in percentage), fat (in percentage), and carbohydrate (in percentage) intake were assessed using food recall and analyzed using NutriSurvey.
Time frame: 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.
Differences in mean anthropometric parameters between the control (low-calorie diet) and intervention (locally adapted Mediterranean diet) groups were analyzed using an unpaired t-test. 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)
Time frame: 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.
Differences in mean nutritional status between the control (low-calorie diet) and intervention (locally adapted Mediterranean diet) groups were analyzed using an unpaired t-test. Nutritional status (Ratio data scale) was categorized based on BMI as underweight (\<18.5), normal (18.5-\<25.0), overweight (25.0-\<27.0), and obesity (≥27.0).
Time frame: 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.
Differences in mean body composition between the control (low-calorie diet) and intervention (locally adapted Mediterranean diet) groups were analyzed using an unpaired t-test. Body composition was assessed using multi-frequency bioelectrical impedance analysis (MF-BIA) and included measurements of BMI, fat mass (in percentage), fat mass index (in percentage), energy stored in body (in Kilocalorie), Resting Energy Expenditure (in Kilocalorie), Total Energy Expenditure (in Kilocalorie), fat free mass (in percentage), Fat Free Mass Index, skeletal muscle mass (in percentage), Total Body Water (in percentage), Extra Cellular Water (in percentage), Bioelectrical Impedance Vector Analysis, visceral fat (in grams), dan phase angle.
Time frame: 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.
Changes in the mean levels of IL-6 before and after diet administration were analyzed using either a dependent t-test or the Wilcoxon signed-rank test, as appropriate. IL-6 (interleukin-6) levels were measured using 100 µL of blood plasma with the sandwich enzyme-linked immunosorbent assay (ELISA) method using a Human IL-6 ELISA Kit. IL-6 levels (nanograms/mililiter) are expressed on a ratio scale.
Time frame: 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.
Changes in the mean levels of I-FABP before and after diet administration were analyzed using either a dependent t-test or the Wilcoxon signed-rank test, as appropriate. Intestinal fatty acid-binding protein (I-FABP) concentrations were measured in 100 µL of plasma using a Human I-FABP ELISA Kit employing the sandwich ELISA method. I-FABP concentrations (nanograms/mililiter) are reported on a ratio scale.
Time frame: 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.
Changes in the mean levels of TyG index before and after diet administration were analyzed using either a dependent t-test or the Wilcoxon signed-rank test, as appropriate. The triglyceride-glucose (TyG) index was calculated from 3 µL of plasma based on fasting triglyceride (TG) and fasting plasma glucose (FPG) concentrations using the following formula: ln \[fasting TG (mg/dL) × FPG (mg/dL) / 2\].
Time frame: 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.
Gut Microbiota: Microbiota diversity (ratio data scale) Gut microbiota diversity was assessed from 250 mg of stool using the QIAGEN QIAamp PowerFecal Pro DNA Kit. DNA concentration and purity were determined by NanoDrop spectrophotometry and agarose gel electrophoresis
Time frame: 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.
Metabolomic profiling (ratio data scale) was conducted on 100 µL of plasma using the Shimadzu GCMS-QP2020 NX system.
Time frame: the data were collected at baseline (week 0) and at week 4 of the study.
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