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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:
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).
Design
a. Randomized controlled trial with pre-post design
Intervention :
Outcome
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
Protocol Analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | This group will receive dietary adjustment and nutrition counseling. |
|
| Control | Active Comparator | This group will receive standard diet and nutrition counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Nusantara | Dietary Supplement | 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 |
| 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 |
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Inclusion Criteria:
Fulfill the definition of metabolic syndrome
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agussalim Bukhari, MD. PhD | Contact | +628241850858 | agussalim.bukhari@med.unhas.ac.id |
| Name | Affiliation | Role |
|---|---|---|
| Agussalim Bukhari, MD.Phd | Hasanuddin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wahidin Sudirohusodo General Hospital | Recruiting | Makassar | South Sulawesi | 76124 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31921359 | Background | Sigit FS, Tahapary DL, Trompet S, Sartono E, Willems van Dijk K, Rosendaal FR, de Mutsert R. The prevalence of metabolic syndrome and its association with body fat distribution in middle-aged individuals from Indonesia and the Netherlands: a cross-sectional analysis of two population-based studies. Diabetol Metab Syndr. 2020 Jan 7;12:2. doi: 10.1186/s13098-019-0503-1. eCollection 2020. | |
| 28639538 |
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De-identified data in a form of publication supplement will be shared accordingly
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D003920 | Diabetes Mellitus |
| D006949 | Hyperlipidemias |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The intervention will receive a package of dietary intervention + nutrition counseling, whereas the control group will receive only nutrition counseling.
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masking is not feasible according to the study design.
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|
| Nutrition Counseling | Behavioral | Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters. |
|
| Background |
| Rochlani Y, Pothineni NV, Kovelamudi S, Mehta JL. Metabolic syndrome: pathophysiology, management, and modulation by natural compounds. Ther Adv Cardiovasc Dis. 2017 Aug;11(8):215-225. doi: 10.1177/1753944717711379. Epub 2017 Jun 22. |
| 9570335 | Background | Papamandjaris AA, MacDougall DE, Jones PJ. Medium chain fatty acid metabolism and energy expenditure: obesity treatment implications. Life Sci. 1998;62(14):1203-15. doi: 10.1016/s0024-3205(97)01143-0. |
| 15563444 | Background | Lipoeto NI, Agus Z, Oenzil F, Wahlqvist M, Wattanapenpaiboon N. Dietary intake and the risk of coronary heart disease among the coconut-consuming Minangkabau in West Sumatra, Indonesia. Asia Pac J Clin Nutr. 2004;13(4):377-84. |
| 27834920 | Background | de la Iglesia R, Loria-Kohen V, Zulet MA, Martinez JA, Reglero G, Ramirez de Molina A. Dietary Strategies Implicated in the Prevention and Treatment of Metabolic Syndrome. Int J Mol Sci. 2016 Nov 10;17(11):1877. doi: 10.3390/ijms17111877. |
| 28564650 | Background | Goossens GH. The Metabolic Phenotype in Obesity: Fat Mass, Body Fat Distribution, and Adipose Tissue Function. Obes Facts. 2017;10(3):207-215. doi: 10.1159/000471488. Epub 2017 Jun 1. |
| 27894098 | Background | Di Daniele N, Noce A, Vidiri MF, Moriconi E, Marrone G, Annicchiarico-Petruzzelli M, D'Urso G, Tesauro M, Rovella V, De Lorenzo A. Impact of Mediterranean diet on metabolic syndrome, cancer and longevity. Oncotarget. 2017 Jan 31;8(5):8947-8979. doi: 10.18632/oncotarget.13553. |
| 32674241 | Background | Gusnedi, Abdullah M, Witjaksono F, Mansyur M, Nurwidya F, Djuwita R, Dwiriani CM, Fahmida U. Promotion of optimized food-based recommendations to improve dietary practices and nutrient intakes among Minangkabau women of reproductive age with dyslipidemia. Asia Pac J Clin Nutr. 2020;29(2):334-347. doi: 10.6133/apjcn.202007_29(2).0016. |
| D004700 | Endocrine System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |