The Effect of Oral β- Glucan Supplement on Appetite and Insulin Resistance in Non Alcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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The Objective of This Study is Evaluating the Effect of oral β- glucan Supplement on Anthropometric Measurements, Appetite, Insulin Resistance, Liver echogenicity and Enzymes in Non Alcoholic Fatty Liver Patients Treating with Hypocaloric Diet and Vitamin E.

Official Title
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The Effect of Oral β- Glucan Supplement on Anthropometric Measurements, Appetite, Insulin Resistance, Liver Echogenicity and Enzymes in Non Alcoholic Fatty Liver Disease Treating With Hypocaloric Diet and Vitamin E

Conditions
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Non Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Dietary Supplement: β- glucan
* Dietary Supplement: Maltodextrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Non Alcoholic Fatty Liver Disease From Both Sex Age 18-55 years BMI more than 25 Kg/m2 Exclusion Criteria: Alcohol Consumption Pregnancy or lactation or menopause Being a professional athlete A history of cancer Risk of high blood pressure (in the case of drug use) Heart disease - cardiovascular, pulmonary, renal and diabetes Liver transplantation and other chronic or acute Liver diseases such as hepatitis B, C and liver infections The History of inherited disorders affecting the liver A history of autoimmune disease History of food allergies Taking certain medications such as blood pressure control, statins, insulin sensitivity enhancers and hepatotoxic drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: β- glucan<br>8.5 g/d of Oat Supplement Containing 3g β- glucan | Dietary Supplement: β- glucan<br>* 8.5 g/d of Oat Supplement Containing 3g β- glucan<br>|
| Placebo Comparator: Maltodextrin<br>8.5 g/d Maltodextrin | Dietary Supplement: Maltodextrin<br>* 8.5 g/d Maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Echogenicity | Liver Echogenicity Describes by Grade, | 8 weeks | 
| Liver Enzymes | Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anthropometric Measurement WHtR | WHtR (waist to Height ratio) | 4 weeks, 8 weeks | 
| Appetite | NAS (numeric Analuge Scale) cm | 4 weeks, 8 weeks | 
| Insulin Resistance | Describe by HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) | 8 weeeks | 
| Anthropometric Measurement WC | WC (waist circumference) measures by cm | 4weeks, 8 weeks | 
| Anthropometric Measurement WHR | WHR (waist to hip ratio) | 4 weeks, 8 weeks | 
| Anthropometric Measurement BMI | BMI (Body Mass Index) kg/m2 | 4 weeks, 8 weeks | 
| Peptide YY (PYY) Hormone | Elayza kit | 8 weeks | 
| Cholecystokinin (CKK) Hormone | Elayza kit | 8 weeks | 
| Fasting Blood Sugar | FBS (Fasting Blood Sugar) mmol/lit | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Alcoholic Fatty Liver Disease(NAFLD), β- glucan, Appetite, Insulin Resistance