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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566197
• Other study ID #: 0709221426
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: September 2022
• Source: Hasanuddin University
• Contact: Agussalim Bukhari, MD. PhD
• Phone: +628241850858
• Email: agussalim.bukhari[@]med.unhas.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Design

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Fulfill the definition of metabolic syndrome

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:

1. pregnant or breastfeeding women

2. suffer from chronic disease

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemias
• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Wahidin Sudirohusodo General Hospital	Makassar	South Sulawesi

Sponsors (1)

Lead Sponsor	Collaborator
Hasanuddin University

Country where clinical trial is conducted

Indonesia, 

References & Publications (8)

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). pii: E1877. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Papamandjaris AA, MacDougall DE, Jones PJ. Medium chain fatty acid metabolism and energy expenditure: obesity treatment implications. Life Sci. 1998;62(14):1203-15. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Lipid profile	parameters of lipid (total cholesterol, LDL, HDL, Triglyceride) measured from blood sample	changes of lipid profile from baseline to day 56
Primary	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
Primary	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