Diabetes, Hyperlipidemias, Metabolic Syndrome
Conditions
Keywords
Diet Nusantara, Low Calorie, Low Sodium, Lipid Profile, Insulin Resistance
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.
Interventions
DIETARY_SUPPLEMENTDiet 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
BEHAVIORALNutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
Sponsors
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
masking is not feasible according to the study design.
Intervention model description
The intervention will receive a package of dietary intervention + nutrition counseling, whereas the control group will receive only nutrition counseling.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Indonesia
Contacts
Primary ContactAgussalim Bukhari, MD. PhD
Outcome results
None listed