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

Sponsor

Urmia University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02178839

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non Alcoholic Fatty Liver Disease	Dietary Supplement: β- glucan Dietary Supplement: Maltodextrin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: β- glucan 8.5 g/d of Oat Supplement Containing 3g β- glucan	Dietary Supplement: β- glucan 8.5 g/d of Oat Supplement Containing 3g β- glucan
Placebo Comparator: Maltodextrin 8.5 g/d Maltodextrin	Dietary Supplement: Maltodextrin 8.5 g/d Maltodextrin

Arm

Intervention/Treatment

Experimental: β- glucan

8.5 g/d of Oat Supplement Containing 3g β- glucan

Dietary Supplement: β- glucan

8.5 g/d of Oat Supplement Containing 3g β- glucan

Placebo Comparator: Maltodextrin

8.5 g/d Maltodextrin

Dietary Supplement: Maltodextrin

8.5 g/d Maltodextrin

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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