Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome

September 30, 2022 updated by: Bumi Herman, Hasanuddin University

Nusantara Diet (Balance Nutrition With Low Calorie and Low Sodium Diet) Impact on Body Composition, Insulin Resistance, and Lipid Profile in Patients With Risk of Metabolic Syndrome

The goal of this randomized clinical trial is to evaluate the effect of Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome. The main questions it aims to answer are:

  • How effective the Nusantara diet in reducing body mass index and body fat percentage?
  • How effective the Nusantara diet in affecting lipid profile and insulin resistance?

Participants will be given this diet for a period of 56 days and undergo repeated outcome measurement. This study has a comparison group (no intervention) to see the difference of reduction or slope of changes in outcomes. We assumed that the Nusantara diet will reduce the metabolic syndrome indicators (anthropometry, lipid profile, and insulin resistance profile).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Design

a. Randomized controlled trial with pre-post design

Intervention :

  1. Balance Nutrition with low calorie and low sodium. Low calorie means a diet with 500 kilocalories lower than the Basal Energy Expenditure, according to the Harris-Benedict formula. The daily limit of sodium is 2300 mg.
  2. Organoleptic test for set menu
  3. Given as a set for 56 days
  4. Dietary counseling is given before intervention, followed by a 24-hour food recall every week.

Outcome

  1. Body mass index
  2. Blood chemistry test: Total Cholesterol, Low-Density Lipoprotein (LDL), High-density Lipoprotein, Triglyceride,

4. Glucose profile (Fasting blood glucose, and Homeostatic Model Assessment for Insulin Resistance / HOMA-IR) 3. Body Fat percentage using Bioelectrical Impedance Analyzer

Sample Size Estimation With the following assumption

  1. Type I error: 5%
  2. Power of Study: 80%
  3. Superiority Trial
  4. Equal allocation with two arms
  5. Assuming that the reduction of LDL would be 30% of the average LDL level among metabolic syndrome individuals (106.4 mg/dL), the total sample would be 48 participants

Protocol Analysis

  1. Intention-to-treat analysis
  2. Sensitivity analysis and subgroup analysis
  3. If the randomization obtains an equal baseline characteristic, an Independent T-test will be applied.
  4. Regression model will be applied, adjusting any possible confounder.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • 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 Contact

Study Locations

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 76124
        • Recruiting
        • Wahidin Sudirohusodo General Hospital
        • Contact:
        • Principal Investigator:
          • Agussalim Bukhari, MD. Ph.D
        • Sub-Investigator:
          • A. Arsyi Adlina Putri Sadikin, MD
        • Sub-Investigator:
          • Rahma Widiana, MD
        • Sub-Investigator:
          • Yuliastuti Hayat, MD

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

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fulfill the definition of metabolic syndrome

    1. Blood Pressure>135/85 mmHg
    2. Central obesity with waist circumference for males>90 cm or >80 cm in females
    3. Triglyceride level >150 mg/dL, followed by HDL<40 mg/dL
    4. blood fasting glucose >100 mg/dL

Exclusion Criteria:

  1. pregnant or breastfeeding women
  2. suffer from chronic disease

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This group will receive dietary adjustment and nutrition counseling.
Dietary supplement: Diet Nusantara
Diet Nusantara consists of 1700 kilocalories (or 500 kilocalories lower than basal energy expenditure) on first month and subsequent reduction for the following months (200 kilocalories). The participants should also limit the sodium intake not more than 2300 mg daily
Behavioral: Nutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
Active Comparator: Control
This group will receive standard diet and nutrition counseling.
Behavioral: Nutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: changes of body mass index from baseline to day 56
Defined as body weight in kilogram defined by square of body height in meter. Higher number indicates obesity
changes of body mass index from baseline to day 56
Lipid profile
Time Frame: changes of lipid profile from baseline to day 56
parameters of lipid (total cholesterol, LDL, HDL, Triglyceride) measured from blood sample
changes of lipid profile from baseline to day 56
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time Frame: changes of HOMA-IR from baseline to day 56
HOMA-IR was calculated according to the formula: fasting insulin x fasting glucose/22.5.
changes of HOMA-IR from baseline to day 56
Body Fat Percentage
Time Frame: changes of Body Fat Percentage from baseline to day 56
Body Fat Percentage is the total mass of fat divided by total body mass, multiplied by 100. This is measured by Bioelectrical Impedance Analyzer.
changes of Body Fat Percentage from baseline to day 56

Collaborators and Investigators

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

Sponsor

Hasanuddin University

Investigators

  • Principal Investigator: Agussalim Bukhari, MD.Phd, Hasanuddin University

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)

July 15, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0709221426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

De-identified data in a form of publication supplement will be shared accordingly

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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