Clinical trial NCT05566197: Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Diabetes
Hyperlipidemias
Keywords: Diet Nusantara
Low Calorie
Low Sodium
Lipid Profile
Insulin Resistance
Lead sponsor: Hasanuddin University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will receive a package of dietary intervention + nutrition counseling, whereas the control group will receive only nutrition counseling.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Mass Index
timeFrame: changes of body mass index from baseline to day 56
measure: Lipid profile
timeFrame: changes of lipid profile from baseline to day 56
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: changes of HOMA-IR from baseline to day 56
measure: Body Fat Percentage
timeFrame: changes of Body Fat Percentage from baseline to day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Makassar
country: Indonesia
facility: Wahidin Sudirohusodo General Hospital
state: South Sulawesi
Study officials:
affiliation: Hasanuddin University
name: Agussalim Bukhari, MD.Phd
role: PRINCIPAL_INVESTIGATOR
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