Effects of Balanced and Sustainable Diet Application for Insulin Resistance and Inflammation Marker of Obese People

Obesity Clinical Trial

Official title:

The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469869
• Other study ID #: YULIA-SAMI project
• Status: Completed
• Phase: N/A
• Start date: March 16, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of balanced and sustainable diet application on fat composition, insulin resistance and inflammation marker in obese people.

Intervention: Obese subject will receive intervention on balanced and sustainable diet application Control: Obese subject will receive a balanced diet application only

Description:

Maintaining the adherence of weight loss programme while selecting healthy and sustainable foods will become a worldwide future challenge in nutrition. Therefore, we investigated the suitable content, graphic, and flow in developing a mobile application as an alternative solution for enhancing the compliance of weight control and selecting healthy food with the least environmental impact.

The treatment for obesity consists of dieting, physical exercise, pharmacology, and surgery. Restricted balanced diet is a well known diet recommendation for people with obesity. Sustainable diet is an alternative form of diet which contributes to healthy life and is protective of biodiversity.

The main challenge in obesity management is the sustainability of weight loss programme. Mobile apps are an alternative solution for enhancing compliance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 59 Years

Eligibility

Inclusion Criteria:

• Body mass index = 25 kg/m2

• using Android-based smartphone

• willing to join this research by signing informed consent

Exclusion Criteria:

• pale in physical examination

• in weight loss program

• have obesity with comorbidities

• have hormonal diseases

• consumed hormonal drug, PTU, anti diabetes drug

• smoking or stop smoking under 2 years

• pregnant and breastfeeding women

Related Conditions & MeSH terms

• Blood Glucose, High
• Hyperglycemia
• Inflammation
• Insulin Resistance
• Obesity

Intervention

Other:
• balanced and sustainable diet
the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp. the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.

Locations

Country	Name	City	State
Indonesia	University of Indonesia	Depok	West Java

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of body weight	Change from baseline body weight at 8 weeks, is measured in kg	baseline at Day0 and endline at Day56
Secondary	Change of Fat Mass	Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg	baseline at Day0 and endline at Day56
Secondary	Change of Fasting plasma glucose	Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL	baseline at Day0 and endline at Day56
Secondary	Change of TNF alpha	Change from baseline TNF alpha at 8 weeks, is measured in pg/ml	baseline at Day0 and endline at Day56
Secondary	Change of Fasting Insulin	Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL	baseline at Day0 and endline at Day56
Secondary	Change of HOMA-IR	Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405	baseline at Day0 and endline at Day56
Secondary	Change of Waist Circumference	Change from baseline Waist Circumference at 8 weeks, is measured in cm	baseline at Day0 and endline at Day56
Secondary	Change of Carbohydrate intake	Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall	baseline at Day0 and endline at Day56
Secondary	Change of Fat intake	Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall	baseline at Day0 and endline at Day56
Secondary	Change of Protein intake	Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall	baseline at Day0 and endline at Day56