Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome
NCT ID: NCT05566197
Last Updated: 2022-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2022-07-15
2023-02-01
Brief Summary
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* 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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
This group will receive dietary adjustment and nutrition counseling.
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
Nutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
Control
This group will receive standard diet and nutrition counseling.
Nutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
Interventions
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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
Nutrition Counseling
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
Eligibility Criteria
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Inclusion Criteria
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
2. suffer from chronic disease
18 Years
60 Years
ALL
Yes
Sponsors
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Hasanuddin University
OTHER
Responsible Party
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Bumi Herman
Assistant Lecturer
Principal Investigators
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Agussalim Bukhari, MD.Phd
Role: PRINCIPAL_INVESTIGATOR
Hasanuddin University
Locations
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Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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0709221426
Identifier Type: -
Identifier Source: org_study_id
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