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

Not Applicable

Completed

• Conditions: Metabolic Syndrome, Protection Against
• Interventions: Other: Nutritionally balanced low-calorie diet

• Registration Number: NCT05703438
• Lead Sponsor: Andalas University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-08-05
• Primary Completion: 2022-12-04
• Study Completion: 2022-12-04
• Study First Submitted: 2022-12-05
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nutritionally balanced low-calorie diet	Nutritionally balanced low-calorie diet	Experimental study with pre and post design

Primary Outcome Measures

Name	Time	Method
Change from baseline fat mass percentage at 8 weeks.	up to 8 weeks	Measured using bioimpedance analysis (BIA)
Change from baseline body mass index at 8 weeks.	up to 8 weeks	A person's weight in kilograms divided by the square of height in meters
Change from baseline systolic and diastolic blood pressure at 8 weeks.	up to 8 weeks	Measured using a digital sphygmomanometer
Change from baseline fasting blood sugar levels at 8 weeks.	up to 8 weeks	Measured using clinical chemistry analyzer
Change from baseline waist circumference at 8 weeks.	up to 8 weeks	The measurement taken around the abdomen at the level of the umbilicus (belly button).
Change from baseline lipid profile levels at 8 weeks.	up to 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).

Trial Locations

Locations (1)

Universitas Andalas; 🇮🇩 Padang, Sumatera Barat, Indonesia