Non Alcoholic Fatty Liver DiseaseNCT02178839
The Effect of Oral β- Glucan Supplement on Appetite and Insulin Resistance in Non Alcoholic Fatty Liver Disease
A study testing β- glucan and Maltodextrin in people with Non Alcoholic Fatty Liver Disease, run by Urmia University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Non Alcoholic Fatty Liver Disease
- What is being tested?
- β- glucan and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Jul 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Non Alcoholic Fatty Liver Disease From Both Sex
- Age 18-55 years
- BMI more than 25 Kg/m2
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site
Shekh-al- rais Clinic
Tabriz
Navideh Youshari, MSc. Student, navideh_youshari@yahoo.co.uk
Mohammad Alizadeh, PhD
About this study
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
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
- Being tested
- β- glucan, Maltodextrin
- Keywords
- Non Alcoholic Fatty Liver Disease(NAFLD), β- glucan, Appetite, Insulin Resistance
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β- glucanDietary supplement
8.5 g/d of Oat Supplement Containing 3g β- glucan
MaltodextrinDietary supplement
8.5 g/d Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| β- glucan | Experimental | 8.5 g/d of Oat Supplement Containing 3g β- glucan Receives: Dietary Supplement: β- glucan |
| Maltodextrin | Placebo comparator | 8.5 g/d Maltodextrin Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Echogenicity
Liver Echogenicity Describes by Grade,
Measured: 8 weeks
Liver Enzymes
Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase)
Measured: 8 weeks
Secondary outcomes (9)
Anthropometric Measurement WHtR
WHtR (waist to Height ratio)
Measured: 4 weeks, 8 weeks
Appetite
NAS (numeric Analuge Scale) cm
Measured: 4 weeks, 8 weeks
Insulin Resistance
Describe by HOMA-IR (Homeostasis Model Assessment of Insulin Resistance)
Measured: 8 weeeks
Anthropometric Measurement WC
WC (waist circumference) measures by "cm"
Measured: 4weeks, 8 weeks
Anthropometric Measurement WHR
WHR (waist to hip ratio)
Measured: 4 weeks, 8 weeks
Anthropometric Measurement BMI
BMI (Body Mass Index) kg/m2
Measured: 4 weeks, 8 weeks
Peptide YY (PYY) Hormone
Elayza kit
Measured: 8 weeks
Cholecystokinin (CKK) Hormone
Elayza kit
Measured: 8 weeks
Fasting Blood Sugar
FBS (Fasting Blood Sugar) mmol/lit
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Urmia University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Alizadeh, PhD, Principal investigator, Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178839
- Sponsor's protocol ID
- umsu.rec.1393.48
- Status last verified
- Jun 2014
- First submitted
- 18 Jun 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02178839
- Acronym / sponsor ID
- umsu.rec.1393.48
- Conditions
- Non Alcoholic Fatty Liver Disease
- Keywords
- Non Alcoholic Fatty Liver Disease(NAFLD), β- glucan, Appetite, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Urmia University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (estimated)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| β- glucan | Experimental | Dietary Supplement: β- glucan8.5 g/d of Oat Supplement Containing 3g β- glucan |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin8.5 g/d Maltodextrin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with Non Alcoholic Fatty Liver Disease From Both Sex
- Age 18-55 years
- BMI more than 25 Kg/m2
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| β- glucan8.5 g/d of Oat Supplement Containing 3g β- glucan | Dietary supplement | β- glucan |
| Maltodextrin8.5 g/d Maltodextrin | Dietary supplement | Maltodextrin |
Primary outcome
Liver Echogenicity
Time frame: 8 weeks
Liver Echogenicity Describes by Grade,
Liver Enzymes
Time frame: 8 weeks
Enzymes ALP (Alkanin Phosphatase), ALT (Alanin Amino Transferase) and AST (Aspartat Amino Transferase)
9 secondary outcomes
Anthropometric Measurement WHtR
Time frame: 4 weeks, 8 weeks
Appetite
Time frame: 4 weeks, 8 weeks
Insulin Resistance
Time frame: 8 weeeks
Anthropometric Measurement WC
Time frame: 4weeks, 8 weeks
Anthropometric Measurement WHR
Time frame: 4 weeks, 8 weeks
Anthropometric Measurement BMI
Time frame: 4 weeks, 8 weeks
Peptide YY (PYY) Hormone
Time frame: 8 weeks
Cholecystokinin (CKK) Hormone
Time frame: 8 weeks
Fasting Blood Sugar
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Alizadeh, PhD principal investigator
Department of Nutrition, School of Medicine, Urmia University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing β- glucan and Maltodextrin in people with Non Alcoholic Fatty Liver Disease, run by Urmia University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Echogenicity (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.