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

Study Overview
=================
Brief Summary
-----------------
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).

Detailed Description
-----------------
Design a. Randomized controlled trial with pre-post design Intervention : 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. Organoleptic test for set menu Given as a set for 56 days Dietary counseling is given before intervention, followed by a 24-hour food recall every week. Outcome Body mass index 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 Type I error: 5% Power of Study: 80% Superiority Trial Equal allocation with two arms 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 Intention-to-treat analysis Sensitivity analysis and subgroup analysis If the randomization obtains an equal baseline characteristic, an Independent T-test will be applied. Regression model will be applied, adjusting any possible confounder.

Official Title
-----------------
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

Conditions
-----------------
Metabolic Syndrome, Diabetes, Hyperlipidemias

Intervention / Treatment
-----------------
* Dietary Supplement: Diet Nusantara
* Behavioral: Nutrition Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fulfill the definition of metabolic syndrome Blood Pressure>135/85 mmHg Central obesity with waist circumference for males>90 cm or >80 cm in females Triglyceride level >150 mg/dL, followed by HDL<40 mg/dL blood fasting glucose >100 mg/dL Exclusion Criteria: pregnant or breastfeeding women suffer from chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention will receive a package of dietary intervention + nutrition counseling, whereas the control group will receive only nutrition counseling.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will receive dietary adjustment and nutrition counseling. | Dietary Supplement: Diet Nusantara<br>* 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<br>Behavioral: Nutrition Counseling<br>* Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.<br>|
| Active Comparator: Control<br>This group will receive standard diet and nutrition counseling. | Behavioral: Nutrition Counseling<br>* Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | 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 | 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) | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet Nusantara, Low Calorie, Low Sodium, Lipid Profile, Insulin Resistance