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

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ClinicalTrials.gov Identifier: NCT02178839
Recruitment Status : Unknown
Verified June 2014 by Urmia University of Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Urmia University of Medical Sciences

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 2014
Estimated Primary Completion Date : March 2015


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




Primary Outcome Measures :
  1. Liver Echogenicity [ Time Frame: 8 weeks ]
    Liver Echogenicity Describes by Grade,

  2. Liver Enzymes [ Time Frame: 8 weeks ]
    Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase)


Secondary Outcome Measures :
  1. Anthropometric Measurement WHtR [ Time Frame: 4 weeks, 8 weeks ]
    WHtR (waist to Height ratio)

  2. Appetite [ Time Frame: 4 weeks, 8 weeks ]
    NAS (numeric Analuge Scale) cm

  3. Insulin Resistance [ Time Frame: 8 weeeks ]
    Describe by HOMA-IR (Homeostasis Model Assessment of Insulin Resistance)

  4. Anthropometric Measurement WC [ Time Frame: 4weeks, 8 weeks ]
    WC (waist circumference) measures by "cm"

  5. Anthropometric Measurement WHR [ Time Frame: 4 weeks, 8 weeks ]
    WHR (waist to hip ratio)

  6. Anthropometric Measurement BMI [ Time Frame: 4 weeks, 8 weeks ]
    BMI (Body Mass Index) kg/m2

  7. Peptide YY (PYY) Hormone [ Time Frame: 8 weeks ]
    Elayza kit

  8. Cholecystokinin (CKK) Hormone [ Time Frame: 8 weeks ]
    Elayza kit

  9. Fasting Blood Sugar [ Time Frame: 8 weeks ]
    FBS (Fasting Blood Sugar) mmol/lit



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178839


Locations
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Iran, Islamic Republic of
Shekh-al- rais Clinic Not yet recruiting
Tabriz, Iran, Islamic Republic of
Contact: Navideh Youshari, MSc. Student       navideh_youshari@yahoo.co.uk   
Principal Investigator: Mohammad Alizadeh, PhD         
Principal Investigator: Mehrangiz Ebrahimi Mameghani, PhD         
Sponsors and Collaborators
Urmia University of Medical Sciences
Investigators
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Principal Investigator: Mohammad Alizadeh, PhD Department of Nutrition, School of Medicine, Urmia University of Medical Sciences

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Responsible Party: Urmia University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02178839     History of Changes
Other Study ID Numbers: umsu.rec.1393.48
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by Urmia University of Medical Sciences:
Non Alcoholic Fatty Liver Disease(NAFLD)
β- glucan
Appetite
Insulin Resistance

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Liver Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs