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
This randomized single blind controlled clinical trial will be performed to investigate the effect of Hydroxy citric acid on hepcidin level of serum and liver enzyme levels and sonographic image on 40 women that are 18-50 years old with NAFLD confirmed by sonographic image that will be with moderate level of physical activity and BMI of 27/5-40 kg/m2 and not being lactation or pregnant or menopause ,without any liver diseases or metabolic disorders such as diabet or thyroid disorders and not using drugs for liver disorders. Patients will be randomized in 2 groups:control group that will get just weight loss diet,also intervention group get weight loss diet plus 6 tablets of Hydroxy citric acid supplements derived from Garcinia Cambogia (two tablets,30 minutes before breakfast,lunch,dinner) daily for 2 months.at baseline and at the end of study from all of the participants will be taken 7 cc blood samples after 12 hours fasting for measuring hepcidin level of serum and liver enzymes.at baseline and at the end of study: sonographic image will take, anthropometric indices will be measured,physical activity questionnaires and appetite questionnaires will be completed. and 24 hours dietary recall at baseline- middle-end of study will be completed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503273320N11
Registration date:2015-07-27, 1394/05/05
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-07-27, 1394/05/05
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences,
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of Hydroxy citric acid on non alcoholic fatty liver disease
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: 18-50 years old liver steatosis on sonographic image; women;
BMI: 27/5- 40 kg/m2; moderate level of physical activity
exclusion criteria:
Pregnancy ;lactation; menopause;alcohol consumption;cigarette smoking;being athletic;diabets or insulin resistance;any other liver diseases( viral diseases; Wilson; hemochromatosis; glycogen storage disorders and etc) ; using drugs for treatments of fatty liver (such as omega 3 and herbal supplements); thyriod and parathyroid disorders;Crohn disease;chronic kidney disorders;Ulcerative colon;sever trauma; any type of cancer;consumption of conteraceptive
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Golgasht street , Tabriz
City
Tariz
Postal code
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
TBZMED.REC.1394.324
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
fatty (change) of liver,not elsewhere classified
Primary outcomes
1
Description
serum level of hepcidin
Timepoint
at baseline,at the end of intervention
Method of measurement
ELIZA Kit
2
Description
liver enzymes( ALT,AST,ALP)
Timepoint
at baseline,at the end of intervention
Method of measurement
IFCC
3
Description
liver steatosis
Timepoint
at baseline,at the end of intervention
Method of measurement
liver sonography
4
Description
Added at 2017-02-13: high sensivity-C Reactive Protein
Timepoint
Added at 2017-02-13: At the baseline and at the end of intervention
Method of measurement
Added at 2017-02-13: immunoturbidometric
5
Description
Added at 2017-02-13: Fasting blood sugar
Timepoint
Added at 2017-02-13: At the baseline and at the end of intervention
Method of measurement
Added at 2017-02-13: Radioimmunoassay
6
Description
Added at 2017-02-13: Fasting insulin
Timepoint
Added at 2017-02-13: At the baseline and at the end of intervention
Method of measurement
Added at 2017-02-13: Radioimmunoassay
Secondary outcomes
1
Description
Anthropometry
Timepoint
at baseline and at the end of intervention
Method of measurement
scale,meter,bioelectrical impedance analyzer
2
Description
energy and nutrients intake
Timepoint
at baseline and at the end of intervention
Method of measurement
24- hour dietary recall
Intervention groups
1
Description
intervention group: weight loss diet plus 6 tablets (2 tablets 30 minutes before: breakfast- lunch - dinner) for 2 months
Category
Treatment - Drugs
2
Description
control group: just get weight loss diet for 2 months
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Seikholrais Clinic
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Street address
Azadi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad-Reza Rashidi
Street address
Golgasht street, Tabriz University Of Medical Sciences,No 2 central building,3rd floor-Vice Chancellor for Research of Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nutrition faculty,Tabriz university of medical science
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Ntrition Phd
Other areas of specialty/work
Street address
Golgasht street ,Attar neyshaburi street, nutriton faculty
City
Tabriz
Postal code
Phone
+98 41 3334 1113
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical science- nutrition faculty
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
Nutrition Phd
Other areas of specialty/work
Street address
Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
City
Tabriz
Postal code
Phone
+98 41 3334 1113
Fax
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutirition faculty of Tabriz university of medical science
Full name of responsible person
Solmaz Nomi golzar
Position
student of Master science study of health science nutrition
Other areas of specialty/work
Street address
City
Tabriz
Postal code
Phone
0098
Fax
Email
solmaz.nomgolzari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)