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

NCT05566197 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-10-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hasanuddin University

    lead OTHER

Principal Investigators

  • Agussalim Bukhari, MD.Phd · Hasanuddin University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2022-12-30
Completion
2023-02-01

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566197 on ClinicalTrials.gov