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

Not Applicable

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Dietary Supplement: β- glucan; Dietary Supplement: Maltodextrin

• Registration Number: NCT02178839
• Lead Sponsor: Urmia University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-27
• Last Update Submitted: 2014-06-27
• Study Start: 2014-07
• Study First Posted: 2014-07-01
• Last Update Posted: 2014-07-01
• Primary Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
β- glucan	β- glucan	8.5 g/d of Oat Supplement Containing 3g β- glucan
Maltodextrin	Maltodextrin	8.5 g/d Maltodextrin

Primary Outcome Measures

Name	Time	Method
Liver Echogenicity	8 weeks	Liver Echogenicity Describes by Grade,
Liver Enzymes	8 weeks	Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shekh-al- rais Clinic; 🇮🇷 Tabriz, Iran, Islamic Republic of