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The effects of berberis vulgaris juice on plasma hormonal-metabolic parameters and PPAR-γ gene expression level in patients with benign breast tumor: a randomized controlled clinical trial

Protocol summary

Summary
Objectives: The effect of berberis vulgaris juice on plasma level of hormonal-metabolic parameters, plasma level and gene expression of PPAR-ϓ in patients with benign breast tumor (2)Design:A randomized controlled clinical trial.(3) Setting and conduct: 80 patients with benign breast tumor will be randomly divided into either intervention or control group. In this study, observers in laboratory and nurses for distributing the beverages will be blinded. (4)Participants: The inclusion criteria: Histopathological confirmed benign breast; 15-45 years old; Tendency to corporation in study; Completing informed consent form; Passing atleast 2 year from diagnosing disease; BMI less than the ratio of 35 kilogram to squared meter; Moderately active; Lack of menopause. Exclusion criteria: Energy intake range out of 500-3500; History of consumption cigarette in recent 1 year before diagnosing the disease; Acute chronic disease like other cancers, Cardiovascular disease, Renal disease, Liver disease, Hyperthyroidism and other hormonal disorder before diagnosing the disease (pcos, type 1 diabetes, Hypoglycemia, Adrenal gland malfunction ); Having any kind of bleeding & trauma by self reporting or physician; History of other benign neoplasms; Pregnancy and lactation; Consumption of drugs like glucocorticoids, Blood anticoagulants, Epilepsy-related drugs, HRTs, Fish oil supplements more than 2000 mg per day.(5) Intervention: Subjects in intervention group will receive 480 ml berberis vulgaris juice in lunch & dinner meal. Also In control group subjects will receive 480 ml placebo both in lunch & dinner meal. (6) Main outcome measures (variables): Measuring plasma levels of hormonal-metabolic parameters (IGF-1, Insulin, C-peptide, FBS, IGFBP-1, IGFBP-3) and plasma level and gene expression of PPAR-gamma at baseline & endpoint of intervention

General information

Acronym
BBT
IRCT registration information
IRCT registration number: IRCT2012110511335N2
Registration date: 2013-07-10, 1392/04/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-10, 1392/04/19
Registrant information
Name
Saeed Pirouzpanah
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133575803
Email address
pirouzpanahs@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Faculty of Nutrition, Tabriz University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of berberis vulgaris juice on plasma hormonal-metabolic parameters and PPAR-γ gene expression level in patients with benign breast tumor: a randomized controlled clinical trial
Public title
The effects of berberis vulgaris juice on plasma hormonal-metabolic parameters and PPAR-γ gene expression level in patients with benign breast tumor: a randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Participants: The inclusion criteria: Histopathological confirmed benign breast; 15-45 years old; Tendency to corporation in study; Completing informed consent form; Passing atleast 2 year from diagnosing disease; BMI less than the ratio of 35 kilogram to squared meter; Moderately active; Lack of menopause. Exclusion criteria: Energy intake range out of 500-3500; History of consumption cigarette in recent 1 year before diagnosing the disease; Acute chronic disease like other cancers; Cardiovascular disease like: Renal disease, liver disease, Hyperthyroidism and other hormonal disorder before diagnosing the disease (pcos, type 1 diabetes, Hypoglycemia, adrenal gland malfunction ); Having any kind of bleeding & trauma by self reporting or physician; History of other benign neoplasms; Pregnancy and lactation; Consumption of drugs;like glucocorticoids, blood anticoagulants, Epilepsy-related drugs, HRTs, Fish oil supplements more than 2000 mg per day.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Nutrition, Tabriz University of Medical Sciences
Street address
Attar Neyshabori St., Golgasht St.,
City
Tabriz
Postal code
Approval date
2013-05-28, 1392/03/07
Ethics committee reference number
1960-4-5

Health conditions studied

1

Description of health condition studied
Benign breast tumor
ICD-10 code
D24
ICD-10 code description
Benign neoplasm of breast

Primary outcomes

1

Description
Plasma levels of hormonal-metabolic parameters (IGF-1, Insulin, C-peptide, FBS, IGFBP-1, IGFBP-3) and plasma level and gene expression of PPAR-gamma
Timepoint
Baseline and endpoint of the intervention
Method of measurement
Electrochemiluminescence

Secondary outcomes

1

Description
Gene expression of PPAR-gamma
Timepoint
Baseline and endpoint of the intervention
Method of measurement
Real time RT-PCR

Intervention groups

1

Description
Control groups: 480 ml similar to intervention(suger: 55gr, vitamin c: 80 mg) both in lunch & dinner meal ( a glass in each meal equal to 240ml) for 8 weeks.
Category
Treatment - Drugs

2

Description
Intervention Group: 480 ml berberis vulgaris juice(protein:600mg/500ml; Carbohydrates:55gr/500ml; vitamin c:80mg/500ml; Calcium:50mg/500ml; Sodium:100mg/500ml; fat:10mg/500ml) both in lunch & dinner meal ( a glass in each meal equal to 240ml) for 8 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor-Nejat hospital
Full name of responsible person
Hospital manager
Street address
Hafez st., Azadi Blvd., Tabriz,
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Shakouri, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabori St., Golgasht St
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, Faculty of Nutrition, 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Saeed Pirouzpanah
Position
Nutrition, PhD
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences, Attar Neyshabori St., Golgasht St
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pirouzpanahs@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Saeed Pirouzpanah
Position
Nutrition, PhD
Other areas of specialty/work
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences, Attar Neyshabori St., Golgasht St
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
pirouzpanahs@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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