Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome

NCT05566197 | Unknown

• 1 other identifier: 0709221426
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolic Syndrome; Diabetes; Hyperlipidemias

Keywords

Diet Nusantara; Low Calorie; Low Sodium; Lipid Profile; Insulin Resistance

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

This group will receive dietary adjustment and nutrition counseling.

Dietary Supplement: Diet Nusantara; Behavioral: Nutrition Counseling

Control

ACTIVE COMPARATOR

This group will receive standard diet and nutrition counseling.

Behavioral: Nutrition Counseling

Interventions

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

Intervention

Nutrition Counseling BEHAVIORAL

Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.

Control; Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Fulfill the definition of metabolic syndrome
• Blood Pressure\>135/85 mmHg
• Central obesity with waist circumference for males\>90 cm or \>80 cm in females
• Triglyceride level \>150 mg/dL, followed by HDL\<40 mg/dL
• blood fasting glucose \>100 mg/dL

You may not qualify if:

• pregnant or breastfeeding women
• suffer from chronic disease

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 76124, Indonesia

RECRUITING

Related Publications (8)

• 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.

  PMID: 31921359 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.

  PMID: 28639538 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.

  PMID: 9570335 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.

  PMID: 15563444 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.

  PMID: 27834920 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.

  PMID: 28564650 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.

  PMID: 27894098 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.

  PMID: 32674241 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus; Hyperlipidemias; Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Agussalim Bukhari, MD.Phd

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agussalim Bukhari, MD. PhD

CONTACT

+628241850858; agussalim.bukhari@med.unhas.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: masking is not feasible according to the study design.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: The intervention will receive a package of dietary intervention + nutrition counseling, whereas the control group will receive only nutrition counseling.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: July 15, 2022
• Primary Completion: December 30, 2022
• Study Completion: February 1, 2023
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)