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

June 27, 2014 updated by: Urmia University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urmia University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • umsu.rec.1393.48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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