The Effect of a Low-calorie Diet With Balanced Nutrition on Metabolic Syndrome

Study Overview
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Brief Summary
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The study looked at how a nutritionally balanced low-calorie diet based on traditional Indonesian foods affected obese people's metabolic biomarkers. The traditional Indonesian foods presented here are Minangkabau cuisine. Body mass index, waist circumference, systolic and diastolic blood pressure, body fat mass percentage, fasting blood sugar levels, and lipid profiles are among the metabolic biomarkers measured. The provision of a balanced nutritionally low-calorie diet based on traditional Indonesian foods, according to the researchers, will have a significant effect on the metabolic biomarkers of obese people.

Detailed Description
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The research was carried out at RSUP dr. M. Djamil Padang. The research ethics commission of Andalas University's Faculty of Medicine granted the study an ethical permit. Health workers with a BMI of more than 25 kg/m2 became the study population, and officers who agreed to participate in the study after filling out the informed consent form were included in the study. There were 91 people in the study. The study lasted eight weeks (56 days). A week before the study, participants were interviewed about their daily intake using 24-hour food recall, and anthropometric measurements were taken using calibrated tools and performed by trained officers. Subjects underwent a one-week pre-treatment period (baseline period, beginning on D-day 6 and ending on D-day 0), during which they were asked not to take any supplements. All participants had their anthropometric measurement, blood pressure, body fat percentage, fasting blood sugar levels, and lipid profile checked on day 0 and day 57. The Nutrisurvey 2005 application was used to process the daily intake of participants obtained from a 24-hour food recall interview. Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake. A Minangkabau food menu is provided as part of the diet. Participants are given a list of daily menus, which include breakfast, lunch, and dinner. Researchers provided lunch for study participants, while breakfast and dinner were prepared independently by participants using the dietary guidelines and menus provided. Participants kept a food diary, which was collected and evaluated twice a week. The research team also controls and motivates all participants via Whatsapp groups. The study's findings were analyzed using the SPSS software.

Official Title
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The Effect of a Nutritionally Balanced Low Calorie Diet Based on Traditional Indonesian Foods on Obese People's Metabolic Biomarkers

Conditions
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Metabolic Syndrome, Protection Against

Intervention / Treatment
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* Other: Nutritionally balanced low-calorie diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Employee of RSUP dr. M. Djamil, Padang who suffers from obesity (BMI ≥ 25 kg / m2) Willing to follow the research by signing an informed concent Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study was conducted by providing a daily calorie deficit of 500-600 kcal to the usual intake of each participant. The study was conducted for 8 weeks. Examination of metabolic biomarkers is carried out before and after the diet intervention is administered.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritionally balanced low-calorie diet<br>Experimental study with pre and post design | Other: Nutritionally balanced low-calorie diet<br>* Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline body mass index at 8 weeks. | A person's weight in kilograms divided by the square of height in meters | up to 8 weeks | 
| Change from baseline waist circumference at 8 weeks. | The measurement taken around the abdomen at the level of the umbilicus (belly button). | up to 8 weeks | 
| Change from baseline systolic and diastolic blood pressure at 8 weeks. | Measured using a digital sphygmomanometer | up to 8 weeks | 
| Change from baseline fat mass percentage at 8 weeks. | Measured using bioimpedance analysis (BIA) | up to 8 weeks | 
| Change from baseline fasting blood sugar levels at 8 weeks. | Measured using clinical chemistry analyzer | up to 8 weeks | 
| Change from baseline lipid profile levels at 8 weeks. | The lipid profile examined included total cholesterol, triglycerides, HDL (high density lipoprotein) cholesterol, and LDL (low density lipoprotein) cholesterol. Measured using clinical chemistry analyzer (photometer). | up to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritionally balanced low-calorie diet, Archipelago diet, Metabolic biomarkers