The Effect of Oral β- Glucan Supplement on Appetite and I... | NCT02178839

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

NCT02178839

Sponsor

Urmia University of Medical Sciences

Status

Unknown status

Last Update Posted

Jul 1, 2014Estimated

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Non Alcoholic Fatty Liver Disease

Interventions

β- glucan
Maltodextrin

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Mar 2015Estimated

Completion Date

Not provided

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 27, 2014

First Posted Date

Jul 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2014

Last Update Posted Date

Jul 1, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
β- glucan	Dietary Supplement	8.5 g/d of Oat Supplement Containing 3g β- glucan	β- glucan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Anthropometric Measurement WHtR	WHtR (waist to Height ratio)	4 weeks, 8 weeks
Appetite	NAS (numeric Analuge Scale) cm	4 weeks, 8 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Alizadeh, PhD	Department of Nutrition, School of Medicine, Urmia University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shekh-al- rais Clinic		Tabriz			Iran

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D006946	Hyperinsulinism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C008315	maltodextrin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided