Protocol summary
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Study aim
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The aim of the present study is to investigate the effects of a weight loss diet with or without Hydroxy citric acid supplementation on hepcidin level of serum and liver enzymes and sonographic image in obese women with Non Alcoholic Fatty Liver Disease .
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Design
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Single-blind randomized clinical trial
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Settings and conduct
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The study will be conducted in the Sheikh Alrais clinic of Tabriz University of Medical Sciences, and supplementation duration will be 8 weeks.Patients will be blinded to the supplement they will receive.
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Participants/Inclusion and exclusion criteria
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40 patients with non alcoholic fatty liver disease and BMI of 30-40 Kg/m2 will be included in the study. Pregnancy, lactation, and co-morbidity of other metabolic or anemia or thalassemia are among the exclusion criteria of the study.
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Intervention groups
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The subjects in both groups will receive a weight loss diet considering their dietary habits. Patients in the intervention group will get 6 HCA tablets (2 tablets before breakfast, lunch, dinner).
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Main outcome variables
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Serum level of hepcidin, leptin, adiponectin, interlukin1-B, interlukin6, tumer necrosis a, ferritin,hemoglubin glycosilated A1C; Liver enzymes;Lipid profile,hs-crp;FBS; fasting insulin, sonographic image;
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201503273320N11
Registration date:
2015-07-27, 1394/05/05
Registration timing:
prospective
Last update:
2018-05-05, 1397/02/15
Update count:
1
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Registration date
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2015-07-27, 1394/05/05
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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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Vice Chancellor for Research of Tabriz University of Medical Sciences,
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Expected recruitment start date
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2015-08-01, 1394/05/10
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Expected recruitment end date
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2015-12-01, 1394/09/10
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Actual recruitment start date
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2015-08-01, 1394/05/10
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Actual recruitment end date
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2015-12-01, 1394/09/10
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Trial completion date
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empty
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Scientific title
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The effect of weight loss diet with and without Hydroxy citric Acid supplement derived from Garcinia Cambogia on the serum hepcidin level and liver function in women with NAFLD: A randomized controlled clinical trial
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Public title
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The effect of Hydroxy citric acid on non alcoholic fatty liver disease
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
non-menopausal women with Non Alcoholic Fatty Liver Dieases 18-50 years
BMI=27/5-40 kg/m2
moderate activity level
Exclusion criteria:
pregnancy or lactation
alcohol consumption
smoking
anemia or thalassemia
other metabolic disorders
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Age
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From 18 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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From among the patients who volunteer to participate in the study, 40 individuals will be selected by 4-blocks were randomly dهvided in 2 groups ( intervention and control) .
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (HCA) received by each group.
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Placebo
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Not 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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2015-07-06, 1394/04/15
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Ethics committee reference number
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TBZMED.REC.1394.324
Health conditions studied
1
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Description of health condition studied
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Non alcoholic fatty liver disease
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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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serum level of hepcidin
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Timepoint
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at baseline,at the end of intervention
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Method of measurement
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ELIZA Kit
2
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Description
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liver enzymes( ALT,AST,ALP)
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Timepoint
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at baseline,at the end of intervention
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Method of measurement
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IFCC
3
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Description
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liver steatosis
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Timepoint
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at baseline,at the end of intervention
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Method of measurement
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liver sonography
4
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Description
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Added at 2017-02-13: high sensivity-C Reactive Protein
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Timepoint
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Added at 2017-02-13: At the baseline and at the end of intervention
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Method of measurement
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Added at 2017-02-13: immunoturbidometric
5
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Description
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Added at 2017-02-13: Fasting blood sugar
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Timepoint
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Added at 2017-02-13: At the baseline and at the end of intervention
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Method of measurement
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Added at 2017-02-13: Radioimmunoassay
6
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Description
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Added at 2017-02-13: Fasting insulin
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Timepoint
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Added at 2017-02-13: At the baseline and at the end of intervention
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Method of measurement
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Added at 2017-02-13: Radioimmunoassay
7
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Description
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Fasting ferritin
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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ELIZA Kit
8
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Description
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Glycated Hemoglobin
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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High Performance Liquid Chromatography (HPLC)
9
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Description
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Leptin
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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ELIZA Kit
10
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Description
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Adiponectin
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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ELIZA Kit
11
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Description
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Lipid profile ( HDL-C, TG,TC)
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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Enzymetic
12
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Description
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Interleukin-1 beta (IL-1β)
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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ELIZA Kit
13
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Description
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Interleukin- 6
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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ELIZA Kit
14
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Description
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Tumor Necrosis Factor (TNF-a)
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Timepoint
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At the baseline and at the end of intervention
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Method of measurement
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ELIZA Kit
Secondary outcomes
1
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Description
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Anthropometry
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Timepoint
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at baseline and at the end of intervention
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Method of measurement
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scale,meter,bioelectrical impedance analyzer
2
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Description
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energy and nutrients intake
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Timepoint
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at baseline and at the end of intervention
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Method of measurement
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24- hour dietary recall
Intervention groups
1
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Description
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intervention group: weight loss diet plus 6 tablets (2 tablets 30 minutes before: breakfast- lunch - dinner) for 2 months
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Category
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Treatment - Drugs
2
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Description
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control group: just get weight loss diet for 2 months
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Category
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Lifestyle
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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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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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data collected for the primary outcomes will be shared.
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When the data will become available and for how long
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access starting 12 months after publication
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To whom data/document is available
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The data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
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From where data/document is obtainable
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To access the required data, the researchers can contact Ms. Solmaz Nomi Golzar: email address: solmaz.nomgolzari@yahoo.com cellphone number: 0098 9141034898
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What processes are involved for a request to access data/document
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The applicant should provide a brief description of the aims and methods of his Meta-analysis. His request will be assessed by the researchers, and if all of them agree to the request, the requested data will be emailed to the applicant in an Excel file format. All these procedures will take no longer than 15 days.
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Comments
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