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
Sponsor study identifier
interventional
50
1 country
1
Study Start
July 15, 2022
Actual (reported)Primary Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2022
Actual (reported)September 30, 2022
Actual (reported)October 4, 2022
Actual (reported)December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
This group will receive dietary adjustment and nutrition counseling.
This group will receive standard diet and nutrition counseling.
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 consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
Wahidin Sudirohusodo General Hospital
Makassar, South Sulawesi, 76124, Indonesia
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.
Agussalim Bukhari, MD.Phd
Hasanuddin University
First Submitted
September 30, 2022
First Posted
October 4, 2022
Study Start
July 15, 2022
Actual (reported)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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
December 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 4, 2022
Record last verified: 2022-09
De-identified data in a form of publication supplement will be shared accordingly
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Source: ClinicalTrials.gov.
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