Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome
Primary Purpose
Metabolic Syndrome, Diabetes, Hyperlipidemias
Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Diet Nusantara
Nutrition Counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome focused on measuring Diet Nusantara, Low Calorie, Low Sodium, Lipid Profile, Insulin Resistance
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- pregnant or breastfeeding women
- suffer from chronic disease
Sites / Locations
- Wahidin Sudirohusodo General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
This group will receive dietary adjustment and nutrition counseling.
This group will receive standard diet and nutrition counseling.
Outcomes
Primary Outcome Measures
Body Mass Index
Defined as body weight in kilogram defined by square of body height in meter. Higher number indicates obesity
Lipid profile
parameters of lipid (total cholesterol, LDL, HDL, Triglyceride) measured from blood sample
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR was calculated according to the formula: fasting insulin x fasting glucose/22.5.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05566197
First Posted
September 30, 2022
Last Updated
September 30, 2022
Sponsor
Hasanuddin University
1. Study Identification
Unique Protocol Identification Number
NCT05566197
Brief Title
Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasanuddin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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:
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).
Detailed Description
Design
a. Randomized controlled trial with pre-post design
Intervention :
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.
Organoleptic test for set menu
Given as a set for 56 days
Dietary counseling is given before intervention, followed by a 24-hour food recall every week.
Outcome
Body mass index
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
Type I error: 5%
Power of Study: 80%
Superiority Trial
Equal allocation with two arms
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
Intention-to-treat analysis
Sensitivity analysis and subgroup analysis
If the randomization obtains an equal baseline characteristic, an Independent T-test will be applied.
Regression model will be applied, adjusting any possible confounder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Diabetes, Hyperlipidemias
Keywords
Diet Nusantara, Low Calorie, Low Sodium, Lipid Profile, Insulin Resistance
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention will receive a package of dietary intervention + nutrition counseling, whereas the control group will receive only nutrition counseling.
Masking
None (Open Label)
Masking Description
masking is not feasible according to the study design.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group will receive dietary adjustment and nutrition counseling.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
This group will receive standard diet and nutrition counseling.
Intervention Type
Dietary Supplement
Intervention Name(s)
Diet Nusantara
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Nutrition Counseling
Intervention Description
Nutrition counseling consists of the definition of balancing food, metabolic syndrome, exercise, and related health parameters.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
Defined as body weight in kilogram defined by square of body height in meter. Higher number indicates obesity
Time Frame
changes of body mass index from baseline to day 56
Title
Lipid profile
Description
parameters of lipid (total cholesterol, LDL, HDL, Triglyceride) measured from blood sample
Time Frame
changes of lipid profile from baseline to day 56
Title
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Description
HOMA-IR was calculated according to the formula: fasting insulin x fasting glucose/22.5.
Time Frame
changes of HOMA-IR from baseline to day 56
Title
Body Fat Percentage
Description
Body Fat Percentage is the total mass of fat divided by total body mass, multiplied by 100. This is measured by Bioelectrical Impedance Analyzer.
Time Frame
changes of Body Fat Percentage from baseline to day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
pregnant or breastfeeding women
suffer from chronic disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Agussalim Bukhari, MD. PhD
Phone
+628241850858
Email
agussalim.bukhari@med.unhas.ac.id
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agussalim Bukhari, MD.Phd
Organizational Affiliation
Hasanuddin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wahidin Sudirohusodo General Hospital
City
Makassar
State/Province
South Sulawesi
ZIP/Postal Code
76124
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agussalim Bukhari, MD, Ph.D
Phone
+628241850858
Email
agussalim.bukhari@med.unhas.ac.id
First Name & Middle Initial & Last Name & Degree
Agussalim Bukhari, MD. Ph.D
First Name & Middle Initial & Last Name & Degree
A. Arsyi Adlina Putri Sadikin, MD
First Name & Middle Initial & Last Name & Degree
Rahma Widiana, MD
First Name & Middle Initial & Last Name & Degree
Yuliastuti Hayat, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data in a form of publication supplement will be shared accordingly
Citations:
PubMed Identifier
31921359
Citation
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Results Reference
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PubMed Identifier
28639538
Citation
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PubMed Identifier
9570335
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
28564650
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.
Results Reference
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PubMed Identifier
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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.
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Citation
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Results Reference
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Nusantara Diet (Low Calorie and Low Sodium) for Metabolic Syndrome
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