The Effect of a Low-calorie Diet With Balanced Nutrition on Metabolic Syndrome

NCT05703438 | Completed DMC

• 1 other identifier: RKI2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The study looked at how a nutritionally balanced low-calorie diet based on traditional Indonesian foods affected obese people's metabolic biomarkers. The traditional Indonesian foods presented here are Minangkabau cuisine. Body mass index, waist circumference, systolic and diastolic blood pressure, body fat mass percentage, fasting blood sugar levels, and lipid profiles are among the metabolic biomarkers measured. The provision of a balanced nutritionally low-calorie diet based on traditional Indonesian foods, according to the researchers, will have a significant effect on the metabolic biomarkers of obese people.

Conditions

Metabolic Syndrome, Protection Against

Keywords

Nutritionally balanced low-calorie diet; Archipelago diet; Metabolic biomarkers

Outcome Measures

Primary Outcomes (6)

• Change from baseline body mass index at 8 weeks.

  A person's weight in kilograms divided by the square of height in meters

  up to 8 weeks

• Change from baseline waist circumference at 8 weeks.

  The measurement taken around the abdomen at the level of the umbilicus (belly button).

  up to 8 weeks

• Change from baseline systolic and diastolic blood pressure at 8 weeks.

  Measured using a digital sphygmomanometer

  up to 8 weeks

• Change from baseline fat mass percentage at 8 weeks.

  Measured using bioimpedance analysis (BIA)

  up to 8 weeks

• Change from baseline fasting blood sugar levels at 8 weeks.

  Measured using clinical chemistry analyzer

  up to 8 weeks

• Change from baseline lipid profile levels at 8 weeks.

  The lipid profile examined included total cholesterol, triglycerides, HDL (high density lipoprotein) cholesterol, and LDL (low density lipoprotein) cholesterol. Measured using clinical chemistry analyzer (photometer).

  up to 8 weeks

Study Arms (1)

Nutritionally balanced low-calorie diet

EXPERIMENTAL

Experimental study with pre and post design

Other: Nutritionally balanced low-calorie diet

Interventions

Nutritionally balanced low-calorie diet OTHER

Dietary interventions were given with a calorie deficit of 500-600 kcal from the participants' usual daily intake.

Nutritionally balanced low-calorie diet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Employee of RSUP dr. M. Djamil, Padang who suffers from obesity (BMI ≥ 25 kg / m2)
• Willing to follow the research by signing an informed concent

You may not qualify if:

• Did not come and could not be found at the time of research data collection
• Unable to follow the dietary arrangements as set
• Taking anti-diabetic or anti-lipid drugs
• Use of contraceptives or hormonal drugs
• In the treatment of radiotherapy or chemotherapyi

Sponsors & Collaborators

• Andalas University: lead
• Universitas Sumatera Utara: collaborator
• Hasanuddin University: collaborator

Study Sites (1)

Universitas Andalas

Padang, West Sumatra, Indonesia

Location

Related Publications (2)

• Han TS, Lean ME. A clinical perspective of obesity, metabolic syndrome and cardiovascular disease. JRSM Cardiovasc Dis. 2016 Feb 25;5:2048004016633371. doi: 10.1177/2048004016633371. eCollection 2016 Jan-Dec.

  PMID: 26998259 BACKGROUND

• Witjaksono F, Jutamulia J, Annisa NG, Prasetya SI, Nurwidya F. Comparison of low calorie high protein and low calorie standard protein diet on waist circumference of adults with visceral obesity and weight cycling. BMC Res Notes. 2018 Sep 21;11(1):674. doi: 10.1186/s13104-018-3781-z.

  PMID: 30241565 RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nurindrawaty Lipoeto, PhD

  Universitas Andalas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The study was conducted by providing a daily calorie deficit of 500-600 kcal to the usual intake of each participant. The study was conducted for 8 weeks. Examination of metabolic biomarkers is carried out before and after the diet intervention is administered.

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: January 30, 2023
• Study Start: August 5, 2022
• Primary Completion: December 4, 2022
• Study Completion: December 4, 2022
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after publication for 1 year
• Access Criteria: other researcher can contact us trough e-mail.

Locations

ID (1)