Protocol summary
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Study aim
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Determining the effect of cranberry extract on the response to treatment regimen of fatty liver patients on liver enzymes, ultrasound grade, lipid profile and serum glucose levels
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Design
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The study was an intervention and participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind.
The sample size will be 80 people who will receive 50% of the sample volume of cranberry extract and 50% placebo for 6 months and then will be analyzed.
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Settings and conduct
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The study will be performed in the specialized clinic of Imam Reza Hospital in Tabriz.
Participants will receive cranberry extract and placebo as a double-sided blind and data analyzer will also be blind.
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Participants/Inclusion and exclusion criteria
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Entry conditions:
Patients with non-alcoholic fatty liver grade 1, 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
No entry conditions:
Patient dissatisfaction
Rule out the diagnosis of fatty liver
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Intervention groups
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Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver who will receive one cranberry extract daily for 6 months.
Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one plasebo daily for 6 months.
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Main outcome variables
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Determination of lipid profile level before and after cranberry and placebo use
Determination of serum insulin and fasting glucose levels before and after cranberry and placebo
Determination of Ultrasound grade before and after cranberry and placebo
Determination of serum levels of liver enzymes before and after cranberry and placebo
General information
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Reason for update
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for increasing generalizability of result all patients with NAFLD (grade 1-3) were included.
moreover, some confounding factors that affect the result of the study were considered as exclusion criteria such as alcohol consumption and use of vitamin and antioxidant supplements.
we sampled more than anticipated number, 94 patients
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200725048200N1
Registration date:
2020-08-11, 1399/05/21
Registration timing:
registered_while_recruiting
Last update:
2021-06-27, 1400/04/06
Update count:
2
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Registration date
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2020-08-11, 1399/05/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-27, 1399/05/06
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Expected recruitment end date
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2021-07-28, 1400/05/06
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the efficacy of Cranbery in management of non-alcoholic Fatty Liver Patients
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Public title
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Evaluation of the efficacy of Cranbery in treatment of Fatty Liver
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with non-alcoholic fatty liver grade1, 2 and 3
Patients with newly diagnosed fatty liver
Candidates for fatty liver treatment
Exclusion criteria:
Patient dissatisfaction
Rule out the diagnosis of fatty liver
Drug intolerance
Existence of diabetes, , heart, renal and pulmonary failure, other liver diseases in which fatty liver appears in the picture
alcohol consumption
antioxidant and vitamins supplements other that vitamin E
pregnant and lactating mothers
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
94
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants will receive cranberry extract and placebo as a double-sided blind.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-04-20, 1399/02/01
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Ethics committee reference number
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IR.TBZMED.REC.1399.090
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver
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ICD-10 code
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K76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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Determination of lipid profile level before and after cranberry and placebo use
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Timepoint
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Study time and 6 months after taking cranberry extract and placebo
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Method of measurement
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Perform blood tests
2
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Description
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Determination of serum insulin and fasting glucose levels before and after cranberry and placebo
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Timepoint
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Study time and 6 months after taking cranberry extract and placebo
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Method of measurement
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Perform blood tests
3
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Description
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Determination of Ultrasound grade before and after cranberry and placebo
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Timepoint
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Study time and 6 months after taking cranberry extract and placebo
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Method of measurement
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Ultrasound device
4
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Description
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Determination of serum levels of liver enzymes before and after cranberry and placebo
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Timepoint
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Study time and 6 months after taking cranberry extract and placebo
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Method of measurement
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Perform blood tests
Intervention groups
1
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Description
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Intervention group: The first intervention group includes patients with grade 1, 2 and 3 liver.Cranberry extract is called Cranberry Shari, which is the brand name.Ingredients of its formulation 144 mg of cranberry fruit extract (Vaccinium Macrocarporn)،Standardized based on the presence of 25% proanthocyanidin، Equivalent to 36 mg of active ingredient (equivalent to 13 g of dried cranberry fruit).Patients will receive one daily, preferably with food, for 6 months. Possible side effects of the drug include gastrointestinal disorders (nausea and vomiting) and diarrhea (if taken in large amounts) explained to patients in the first session and then in the next sessions the referral will be asked about its possibility.
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Category
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Treatment - Drugs
2
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Description
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Control group: The second intervention group includes patients with grade 1, 2 and 3 liver who will receive one placebo daily for 6 months. The duration of use, the manner of consumption of patient education and follow-up of patients will be completely according to the patients receiving the main drug.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Gastrointestinal and Liver Diseases Research Center, Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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In this study, patients' identities are not shared.
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When the data will become available and for how long
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Access period starts 12 months after the results are published.
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To whom data/document is available
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Data will only be available to researchers in this study.
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Under which criteria data/document could be used
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The data will be available to researchers only for meta-analysis study and for data analysis.
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From where data/document is obtainable
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Receipt of data will be done through the scientific respondent of the study.
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What processes are involved for a request to access data/document
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To receive the data, an email is sent to the scientific respondent and the reason for receiving the data is mentioned in detail and if the reasons are appropriate, the information will be sent.
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Comments
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