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

Non Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02178839
• Other study ID #: umsu.rec.1393.48
• Status: Not yet recruiting
• Phase: N/A
• First received: June 18, 2014
• Last updated: June 27, 2014
• Start date: July 2014

Study information

• Verified date: June 2014
• Source: Urmia University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Non Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• ß- glucan
8.5 g/d of Oat Supplement Containing 3g ß- glucan
• Maltodextrin
8.5 g/d Maltodextrin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shekh-al- rais Clinic	Tabriz

Sponsors (1)

Lead Sponsor	Collaborator
Urmia University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Echogenicity	Liver Echogenicity Describes by Grade,	8 weeks	No
Primary	Liver Enzymes	Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase)	8 weeks	No
Secondary	Anthropometric Measurement WHtR	WHtR (waist to Height ratio)	4 weeks, 8 weeks	No
Secondary	Appetite	NAS (numeric Analuge Scale) cm	4 weeks, 8 weeks	No
Secondary	Insulin Resistance	Describe by HOMA-IR (Homeostasis Model Assessment of Insulin Resistance)	8 weeeks	No
Secondary	Anthropometric Measurement WC	WC (waist circumference) measures by "cm"	4weeks, 8 weeks	Yes
Secondary	Anthropometric Measurement WHR	WHR (waist to hip ratio)	4 weeks, 8 weeks	Yes
Secondary	Anthropometric Measurement BMI	BMI (Body Mass Index) kg/m2	4 weeks, 8 weeks	Yes
Secondary	Peptide YY (PYY) Hormone	Elayza kit	8 weeks	No
Secondary	Cholecystokinin (CKK) Hormone	Elayza kit	8 weeks	No
Secondary	Fasting Blood Sugar	FBS (Fasting Blood Sugar) mmol/lit	8 weeks	Yes