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

NCT02178839 | Unknown

• 1 other identifier: umsu.rec.1393.48
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Alcoholic Fatty Liver Disease

Keywords

Non Alcoholic Fatty Liver Disease(NAFLD); β- glucan; Appetite; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Anthropometric Measurement WHtR

  4 weeks, 8 weeks

• Appetite

  4 weeks, 8 weeks

• Insulin Resistance

  8 weeeks

• Anthropometric Measurement WC

  4weeks, 8 weeks

• Anthropometric Measurement WHR

  4 weeks, 8 weeks

Study Arms (2)

β- glucan

EXPERIMENTAL

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

Dietary Supplement: β- glucan

Maltodextrin

PLACEBO COMPARATOR

8.5 g/d Maltodextrin

Dietary Supplement: Maltodextrin

Interventions

β- glucan DIETARY_SUPPLEMENT

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

β- glucan

Maltodextrin DIETARY_SUPPLEMENT

8.5 g/d Maltodextrin

Maltodextrin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Non Alcoholic Fatty Liver Disease From Both Sex
• Age 18-55 years
• BMI more than 25 Kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Urmia University of Medical Sciences: lead

Study Sites (1)

Shekh-al- rais Clinic

Tabriz, Iran

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Insulin Resistance

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohammad Alizadeh, PhD

  Department of Nutrition, School of Medicine, Urmia University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: July 1, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Last Updated: July 1, 2014

Record last verified: 2014-06

Locations

IR (1)