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Completed

NCT Number: NCT05703438

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

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.

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Key information

Conditions

Metabolic Syndrome, Protection Against Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Andalas

Padang, West Sumatra, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutritionally balanced low-calorie diet

Other

Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake.

Primary outcomes

  1. Change from baseline body mass index at 8 weeks.

    Time frame: up to 8 weeks

    A person's weight in kilograms divided by the square of height in meters

  2. Change from baseline waist circumference at 8 weeks.

    Time frame: up to 8 weeks

    The measurement taken around the abdomen at the level of the umbilicus (belly button).

  3. Change from baseline systolic and diastolic blood pressure at 8 weeks.

    Time frame: up to 8 weeks

    Measured using a digital sphygmomanometer

  4. Change from baseline fat mass percentage at 8 weeks.

    Time frame: up to 8 weeks

    Measured using bioimpedance analysis (BIA)

  5. Change from baseline fasting blood sugar levels at 8 weeks.

    Time frame: up to 8 weeks

    Measured using clinical chemistry analyzer

  6. Change from baseline lipid profile levels at 8 weeks.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Andalas University

Other

Collaborators

  • Hasanuddin University
  • Universitas Sumatera Utara

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 30, 2023
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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