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

Sponsor
Andalas University (Other)
Overall Status
Completed
CT.gov ID
NCT05703438
Collaborator
Universitas Sumatera Utara (Other), Hasanuddin University (Other)
50
1
1
4
12.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nutritionally balanced low-calorie diet
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
The Effect of a Nutritionally Balanced Low Calorie Diet Based on Traditional Indonesian Foods on Obese People's Metabolic Biomarkers
Actual Study Start Date :
Aug 5, 2022
Actual Primary Completion Date :
Dec 4, 2022
Actual Study Completion Date :
Dec 4, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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).

  3. Change from baseline systolic and diastolic blood pressure at 8 weeks. [up to 8 weeks]

    Measured using a digital sphygmomanometer

  4. Change from baseline fat mass percentage at 8 weeks. [up to 8 weeks]

    Measured using bioimpedance analysis (BIA)

  5. Change from baseline fasting blood sugar levels at 8 weeks. [up to 8 weeks]

    Measured using clinical chemistry analyzer

  6. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitas Andalas Padang Sumatera Barat Indonesia

Sponsors and Collaborators

  • Andalas University
  • Universitas Sumatera Utara
  • Hasanuddin University

Investigators

  • Principal Investigator: Nurindrawaty Lipoeto, PhD, Universitas Andalas

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nur Indrawaty Lipoeto, Clinical Professor, Andalas University
ClinicalTrials.gov Identifier:
NCT05703438
Other Study ID Numbers:
  • RKI2022
First Posted:
Jan 30, 2023
Last Update Posted:
Feb 2, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nur Indrawaty Lipoeto, Clinical Professor, Andalas University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 2, 2023