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

January 19, 2023 updated by: Nur Indrawaty Lipoeto, Andalas University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 8 weeks
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).
up to 8 weeks
Change from baseline blood pressure at 8 weeks.
Time Frame: up to 8 weeks
Measured using a digital sphygmomanometer
up to 8 weeks
Change from baseline fat mass percentage at 8 weeks.
Time Frame: up to 8 weeks
Measured using bioimpedance analysis (BIA)
up to 8 weeks
Change from baseline fasting blood sugar levels at 8 weeks.
Time Frame: up to 8 weeks
Measured using clinical chemistry analyzer
up to 8 weeks
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).
up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Andalas University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hasanuddin University
Universitas Sumatera Utara

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nurindrawaty Lipoeto, PhD, Universitas Andalas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 30, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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