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

Primary Purpose

Non Alcoholic Fatty Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
β- glucan
Maltodextrin
Sponsored by
Urmia University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Fatty Liver Disease focused on measuring Non Alcoholic Fatty Liver Disease(NAFLD), β- glucan, Appetite, Insulin Resistance

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Shekh-al- rais Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

β- glucan

Maltodextrin

Arm Description

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

8.5 g/d Maltodextrin

Outcomes

Primary Outcome Measures

Liver Echogenicity
Liver Echogenicity Describes by Grade,
Liver Enzymes
Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase)

Secondary Outcome Measures

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

Full Information

First Posted
June 18, 2014
Last Updated
June 27, 2014
Sponsor
Urmia University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02178839
Brief Title
The Effect of Oral β- Glucan Supplement on Appetite and Insulin Resistance in Non Alcoholic Fatty Liver Disease
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Urmia University of Medical Sciences

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Fatty Liver Disease
Keywords
Non Alcoholic Fatty Liver Disease(NAFLD), β- glucan, Appetite, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
β- glucan
Arm Type
Experimental
Arm Description
8.5 g/d of Oat Supplement Containing 3g β- glucan
Arm Title
Maltodextrin
Arm Type
Placebo Comparator
Arm Description
8.5 g/d Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
β- glucan
Intervention Description
8.5 g/d of Oat Supplement Containing 3g β- glucan
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
8.5 g/d Maltodextrin
Primary Outcome Measure Information:
Title
Liver Echogenicity
Description
Liver Echogenicity Describes by Grade,
Time Frame
8 weeks
Title
Liver Enzymes
Description
Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Anthropometric Measurement WHtR
Description
WHtR (waist to Height ratio)
Time Frame
4 weeks, 8 weeks
Title
Appetite
Description
NAS (numeric Analuge Scale) cm
Time Frame
4 weeks, 8 weeks
Title
Insulin Resistance
Description
Describe by HOMA-IR (Homeostasis Model Assessment of Insulin Resistance)
Time Frame
8 weeeks
Title
Anthropometric Measurement WC
Description
WC (waist circumference) measures by "cm"
Time Frame
4weeks, 8 weeks
Title
Anthropometric Measurement WHR
Description
WHR (waist to hip ratio)
Time Frame
4 weeks, 8 weeks
Title
Anthropometric Measurement BMI
Description
BMI (Body Mass Index) kg/m2
Time Frame
4 weeks, 8 weeks
Title
Peptide YY (PYY) Hormone
Description
Elayza kit
Time Frame
8 weeks
Title
Cholecystokinin (CKK) Hormone
Description
Elayza kit
Time Frame
8 weeks
Title
Fasting Blood Sugar
Description
FBS (Fasting Blood Sugar) mmol/lit
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Alizadeh, PhD
Organizational Affiliation
Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shekh-al- rais Clinic
City
Tabriz
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Navideh Youshari, MSc. Student
Email
navideh_youshari@yahoo.co.uk
First Name & Middle Initial & Last Name & Degree
Mohammad Alizadeh, PhD
First Name & Middle Initial & Last Name & Degree
Mehrangiz Ebrahimi Mameghani, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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