Obesity Clinical Trial
Official title:
The Effect of Balanced and Sustainable Diet for Insulin Resistance and Inflammation Marker of Obese Adults in Indonesia
Verified date | February 2019 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Indonesia | University of Indonesia | Depok | West Java |
Lead Sponsor | Collaborator |
---|---|
Indonesia University | Fakultas Kedokteran Universitas Indonesia |
Indonesia,
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 |
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