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

Metabolic Syndrome, Protection Against Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05703438
• Other study ID #: RKI2022
• Status: Completed
• Phase: N/A
• Start date: August 5, 2022
• Est. completion date: December 4, 2022

Study information

• Verified date: January 2023
• Source: Andalas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 4, 2022
• Est. primary completion date: December 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome, Protection Against
• Syndrome

Intervention

Other:
• Nutritionally balanced low-calorie diet
Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake.

Locations

Country	Name	City	State
Indonesia	Universitas Andalas	Padang	Sumatera Barat

Sponsors (3)

Lead Sponsor	Collaborator
Andalas University	Hasanuddin University, Universitas Sumatera Utara

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

Han TS, Lean ME. A clinical perspective of obesity, metabolic syndrome and cardiovascular disease. JRSM Cardiovasc Dis. 2016 Feb 25;5:2048004016633371. doi: 10.1177/2048004016633371. eCollection 2016 Jan-Dec. — View Citation

Witjaksono F, Jutamulia J, Annisa NG, Prasetya SI, Nurwidya F. Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling. BMC Res Notes. 2018 Sep 21;11(1):674. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change from baseline systolic and diastolic blood pressure at 8 weeks.	Measured using a digital sphygmomanometer	up to 8 weeks
Primary	Change from baseline fat mass percentage at 8 weeks.	Measured using bioimpedance analysis (BIA)	up to 8 weeks
Primary	Change from baseline fasting blood sugar levels at 8 weeks.	Measured using clinical chemistry analyzer	up to 8 weeks
Primary	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