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

Primary Purpose

Metabolic Syndrome, Protection Against

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Nutritionally balanced low-calorie diet
Sponsored by
Andalas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome, Protection Against focused on measuring Nutritionally balanced low-calorie diet, Archipelago diet, Metabolic biomarkers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitas Andalas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nutritionally balanced low-calorie diet

Arm Description

Experimental study with pre and post design

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 5, 2022
Last Updated
January 31, 2023
Sponsor
Andalas University
Collaborators
Universitas Sumatera Utara, Hasanuddin University
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1. Study Identification

Unique Protocol Identification Number
NCT05703438
Brief Title
The Effect of a Low-calorie Diet With Balanced Nutrition on Metabolic Syndrome
Official Title
The Effect of a Nutritionally Balanced Low Calorie Diet Based on Traditional Indonesian Foods on Obese People's Metabolic Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2022 (Actual)
Primary Completion Date
December 4, 2022 (Actual)
Study Completion Date
December 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Andalas University
Collaborators
Universitas Sumatera Utara, Hasanuddin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Protection Against
Keywords
Nutritionally balanced low-calorie diet, Archipelago diet, Metabolic biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritionally balanced low-calorie diet
Arm Type
Experimental
Arm Description
Experimental study with pre and post design
Intervention Type
Other
Intervention Name(s)
Nutritionally balanced low-calorie diet
Intervention Description
Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake.
Primary Outcome Measure Information:
Title
Change from baseline body mass index at 8 weeks.
Description
A person's weight in kilograms divided by the square of height in meters
Time Frame
up to 8 weeks
Title
Change from baseline waist circumference at 8 weeks.
Description
The measurement taken around the abdomen at the level of the umbilicus (belly button).
Time Frame
up to 8 weeks
Title
Change from baseline systolic and diastolic blood pressure at 8 weeks.
Description
Measured using a digital sphygmomanometer
Time Frame
up to 8 weeks
Title
Change from baseline fat mass percentage at 8 weeks.
Description
Measured using bioimpedance analysis (BIA)
Time Frame
up to 8 weeks
Title
Change from baseline fasting blood sugar levels at 8 weeks.
Description
Measured using clinical chemistry analyzer
Time Frame
up to 8 weeks
Title
Change from baseline lipid profile levels at 8 weeks.
Description
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).
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nurindrawaty Lipoeto, PhD
Organizational Affiliation
Universitas Andalas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitas Andalas
City
Padang
State/Province
Sumatera Barat
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
26998259
Citation
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.
Results Reference
background
PubMed Identifier
30241565
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. doi: 10.1186/s13104-018-3781-z.
Results Reference
result

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

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