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

The Effect of a Nutritionally Balanced Low-calorie Diet Based on the Archipelago Diet on Metabolic Biomarkers of Health Workers Suffering From Obesity.

The study examined the effect of a nutritionally balanced low-calorie diet based on the archipelago diet on metabolic biomarkers of health workers suffering from obesity. The archipelago diet given is the food of the Minangkabau people. Metabolic biomarkers assessed include body mass index, waist circumference, blood pressure, body fat mass percentage, fasting blood sugar levels and lipid profiles. Researchers hypothesize the provision of a balanced nutrition low-calorie diet based on an archipelago diet will have a significant effect on the metabolic biomarkers of health workers suffering from obesity.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome, Protection Against
• Intervention / Treatment: Other: Nutritionally balanced low-calorie diet

Detailed Description

The study was conducted at RSUP dr. M. Djamil Padang. The study has obtained an ethical permit from the research ethics commission of the Faculty of Medicine of Andalas University. Health workers with a body mass index of more than 25 kg/m2 became the study population and officers who were willing to take part in the study were included in the study after filling out the inform consent. The study participants numbered 50 people. The study was conducted for 8 weeks (56 days). A week before the study participants were interviewed about daily intake using 24-hour food recall and anthropometric measurements were carried out using tools that had been calibrated and carried out by trained officers. Anthropometric measurements were carried out as many as 3 repetitions and taken on average. Subjects underwent a one-week pre-treatment period (baseline period, starting from D-day 6 to day 0), with a diet as the subject's habit and were asked not to take any kind of supplement. On day 0 and day 57, all participants were checked for blood pressure, body fat percentage, fasting blood sugar levels and lipid profile. Post-interventional anthropometric examination was also carried out on day 57. The daily intake of participants obtained through a 24-hour food recall interview was processed with the Nutrisurvey 2005 application. Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake. The diet is given with a Minangkabau food menu. Participants are made a list of daily menus, including breakfast, lunch and dinner. Researchers provided lunch for study participants while breakfast and dinner were prepared independently by participants according to the dietary guidelines and menus provided. Participants recorded daily intake using a food diary, collected and evaluated every 2 times a week. All participants are also always controlled and motivated by the research team through whattsapp groups. The results of the study were processed with SPSS aplication.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Sumatera Barat
    • Padang, Sumatera Barat, Indonesia
      • Universitas Andalas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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 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

Collaborators and Investigators

• Sponsor: Andalas University
• Collaborators: Hasanuddin University; Universitas Sumatera Utara
• Investigators: Principal Investigator: Nurindrawaty Lipoeto, PhD, Universitas Andalas

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1186/s13104-018-3781-z.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): December 4, 2022
• Study Completion (Actual): December 4, 2022

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Estimate): January 30, 2023

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Metabolic biomarkers; Nutritionally balanced low-calorie diet; Archipelago diet
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: RKI2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: Starting 6 months after publication for 1 year
• IPD Sharing Access Criteria: other researcher can contact us trough e-mail.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No