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

Not Applicable

Recruiting

• Conditions: Metabolic Syndrome; Diabetes; Hyperlipidemias
• Interventions: Behavioral: Nutrition Counseling; Dietary Supplement: Diet Nusantara

• Registration Number: NCT05566197
• Lead Sponsor: Hasanuddin University

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 :

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 Timeline

• Study Start: 2022-07-15
• Status Verified: 2022-09
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Primary Completion: 2022-12-30
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Nutrition Counseling	This group will receive standard diet and nutrition counseling.
Intervention	Nutrition Counseling	This group will receive dietary adjustment and nutrition counseling.
Intervention	Diet Nusantara	This group will receive dietary adjustment and nutrition counseling.

Primary Outcome Measures

Name	Time	Method
Body Mass Index	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
Lipid profile	changes of lipid profile from baseline to day 56	parameters of lipid (total cholesterol, LDL, HDL, Triglyceride) measured from blood sample
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	changes of HOMA-IR from baseline to day 56	HOMA-IR was calculated according to the formula: fasting insulin x fasting glucose/22.5.
Body Fat Percentage	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.

Trial Locations

Locations (1)

Wahidin Sudirohusodo General Hospital; 🇮🇩 Makassar, South Sulawesi, Indonesia