Clinical trial

The Mediterranean Diet Based on Local Foods for Obese Patients

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07461870

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 50 Years

SexFemale

Healthy volunteersAccepted

ConditionObese Subjects

Full registry criteria

Inclusion Criteria: * Women who were obese, as defined by a BMI of at least 27. * Aged 18-50 years * Subjects with a non-shift work schedule * Willing to follow the research procedures and sign the informed consent form. Exclusion Criteria: * 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

Treatments and study arms

Locally Adapted Mediterranean Diet

Other

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.

Low calorie diet

Other

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.

Primary outcomes

The implementation of a locally adapted Mediterranean has the potential to improve anthropometric outcomes profiles in obese.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)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Department of Nutrition, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia🌐 Jakarta Pusat, Jakarta Special Capital Region, Indonesia

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