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

Hasanuddin University

Status: Enrolling

Conditions: Diabetes; Hyperlipidemias; Metabolic Syndrome

Treatments: Dietary Supplement: Diet Nusantara; Behavioral: Nutrition Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT05566197

0709221426

Details and patient eligibility

About

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).

Full 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,

3. 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

This group will receive dietary adjustment and nutrition counseling.

Treatment:

Behavioral: Nutrition Counseling

Dietary Supplement: Diet Nusantara

Control

Active Comparator group

Description:

This group will receive standard diet and nutrition counseling.

Treatment:

Behavioral: Nutrition Counseling