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Metabolic SyndromeNCT05566197

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

A study testing Diet Nusantara and Nutrition Counseling in people with Metabolic Syndrome and Diabetes, run by Hasanuddin University at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Metabolic Syndrome, Diabetes, Hyperlipidemias
What is being tested?
Diet Nusantara and Nutrition Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIndonesia
Study dates
15 Jul 2022to 1 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • pregnant or breastfeeding women
  • suffer from chronic disease

Trial locations and contacts

1 site in 1 country.

Agussalim Bukhari, MD. PhD contact

+628241850858

agussalim.bukhari@med.unhas.ac.id

Indonesia1 site, 1 recruiting

  • Wahidin Sudirohusodo General Hospital

    Makassar, South Sulawesi, 76124

    Agussalim Bukhari, MD, Ph.D, +628241850858, agussalim.bukhari@med.unhas.ac.id

    Agussalim Bukhari, MD. Ph.D

    Recruiting

Other trials in Indonesia

About this study

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

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).

Read the detailed description

Design

  1. 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,
  3. 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.
Being tested
Diet Nusantara, Nutrition Counseling
Keywords
Diet Nusantara, Low Calorie, Low Sodium, Lipid Profile, Insulin Resistance
Medical subject headings
Metabolic Syndrome, Diabetes Mellitus, Hyperlipidemias, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet NusantaraDietary 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

  • Nutrition CounselingBehavioural

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

Study groups in NCT05566197
Study groupRoleWhat they receive
InterventionExperimentalThis group will receive dietary adjustment and nutrition counseling.
Receives: Dietary Supplement: Diet Nusantara; Behavioral: Nutrition Counseling
ControlActive comparatorThis group will receive standard diet and nutrition counseling.
Receives: Behavioral: Nutrition Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Mass Index

    Defined as body weight in kilogram defined by square of body height in meter. Higher number indicates obesity

    Measured: changes of body mass index from baseline to day 56

  2. Lipid profile

    parameters of lipid (total cholesterol, LDL, HDL, Triglyceride) measured from blood sample

    Measured: changes of lipid profile from baseline to day 56

  3. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    HOMA-IR was calculated according to the formula: fasting insulin x fasting glucose/22.5.

    Measured: changes of HOMA-IR from baseline to day 56

  4. 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.

    Measured: changes of Body Fat Percentage from baseline to day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start15 Jul 2022
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion1 Feb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05566197
Sponsor's protocol ID
0709221426
Status last verified
Sep 2022
First submitted
30 Sep 2022
Last updated
4 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified data in a form of publication supplement will be shared accordingly

Publications

  • 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.

    PubMed 31921359

  • 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.

    PubMed 28639538

  • 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.

    PubMed 9570335

  • 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.

    PubMed 15563444

  • 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.

    PubMed 27834920

  • 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.

    PubMed 28564650

  • 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.

    PubMed 27894098

  • 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.

    PubMed 32674241

Questions about this trial

What is this clinical trial studying?

A study testing Diet Nusantara and Nutrition Counseling in people with Metabolic Syndrome and Diabetes, run by Hasanuddin University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Agussalim Bukhari, MD. PhD (+628241850858, agussalim.bukhari@med.unhas.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Mass Index (time frame: changes of body mass index from baseline to day 56). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05566197, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2022.

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