Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome
Study Details
Study Description
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:
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How effective the Nusantara diet in reducing body mass index and body fat percentage?
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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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Design
- Randomized controlled trial with pre-post design
Intervention :
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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.
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Organoleptic test for set menu
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Given as a set for 56 days
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Dietary counseling is given before intervention, followed by a 24-hour food recall every week.
Outcome
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Body mass index
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Blood chemistry test: Total Cholesterol, Low-Density Lipoprotein (LDL), High-density Lipoprotein, Triglyceride,
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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
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Type I error: 5%
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Power of Study: 80%
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Superiority Trial
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Equal allocation with two arms
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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
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Intention-to-treat analysis
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Sensitivity analysis and subgroup analysis
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If the randomization obtains an equal baseline characteristic, an Independent T-test will be applied.
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Regression model will be applied, adjusting any possible confounder.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention This group will receive dietary adjustment and nutrition counseling. |
Dietary Supplement: Diet 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
Behavioral: Nutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
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| Active Comparator: Control This group will receive standard diet and nutrition counseling. |
Behavioral: Nutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Fulfill the definition of metabolic syndrome
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Blood Pressure>135/85 mmHg
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Central obesity with waist circumference for males>90 cm or >80 cm in females
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Triglyceride level >150 mg/dL, followed by HDL<40 mg/dL
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blood fasting glucose >100 mg/dL
Exclusion Criteria:
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pregnant or breastfeeding women
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suffer from chronic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wahidin Sudirohusodo General Hospital | Makassar | South Sulawesi | Indonesia | 76124 |
Sponsors and Collaborators
- Hasanuddin University
Investigators
- Principal Investigator: Agussalim Bukhari, MD.Phd, Hasanuddin University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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