Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03469869
Enrollment
60
Registered
2018-03-19
Start date
2018-03-16
Completion date
2018-10-31
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, High, Inflammation, Insulin Resistance, Obesity

Keywords

Obesity

Brief 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

Detailed 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.

Interventions

OTHERbalanced 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.

Sponsors

Fakultas Kedokteran Universitas Indonesia
CollaboratorOTHER
Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Giving a spesific personal menu through android apps, one group with balance diet menu, and the other with balance and sustainable diet menu. Only di IT knows which person get which type of menu

Intervention model description

One group balance diet One group balance and sustainable diet

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change of body weightbaseline at Day0 and endline at Day56Change from baseline body weight at 8 weeks, is measured in kg

Secondary

MeasureTime frameDescription
Change of Fasting plasma glucosebaseline at Day0 and endline at Day56Change from baseline Fasting plasma glucose at 8 weeks, is measured in mg/dL
Change of TNF alphabaseline at Day0 and endline at Day56Change from baseline TNF alpha at 8 weeks, is measured in pg/ml
Change of Fasting Insulinbaseline at Day0 and endline at Day56Change from baseline Fasting Insulin at 8 weeks, is measured in µU/mL
Change of HOMA-IRbaseline at Day0 and endline at Day56Change from baseline HOMA-IR at 8 weeks, is measured using formulation : glukosa (mg/dL) x insulin (µU/mL)/405
Change of Fat Massbaseline at Day0 and endline at Day56Change from baseline Fat Mass at 8 weeks, is measured by body composition analyzer in kg
Change of Carbohydrate intakebaseline at Day0 and endline at Day56Change from baseline Carbohydrate intake at 8 weeks, is measured in gram using 24HR-recall
Change of Fat intakebaseline at Day0 and endline at Day56Change from baseline Fat intake at 8 weeks, is measured in gram using 24HR-recall
Change of Protein intakebaseline at Day0 and endline at Day56Change from baseline Protein intake at 8 weeks, is measured in gram using 24HR-recall
Change of Waist Circumferencebaseline at Day0 and endline at Day56Change from baseline Waist Circumference at 8 weeks, is measured in cm

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026