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Effect of symbiotic supplement on serum adiponectin, hs-CRP, TNF-α, Apo A1 and Apo-B100 concentration in obese and overweight breast cancer survivors with low calorie diet

Protocol summary

Study aim
Effect of symbiotic supplement on serum adiponectin, Apo A1, TNF-α, hs-CRP and Apo B100 concentration in obese and overweight breast cancer survivors with the low-calorie diet.
Design
randomized, double-blind, consumption of placebo in control group, single center
Settings and conduct
Recruiting and performing the study will take place in oncologist's clinic. participants are randomly divided into intervention and control groups. participants, researchers, and analyser are blinded about groups of study.
Participants/Inclusion and exclusion criteria
participants: Breast cancer survivors Main Inclusion criteria: 1- Female breast cancer survivors 2- Age range (50-75) 3- BMI = 25 - 40 Kg/m2 4- At least one month has passed since the last radiotherapy 5- Type of breast cancer ER/PR+ and HER2- Main Exclusion criteria: 1- Metastasis during the study 2- Failure to follow the weight loss diet 3-Consumption less than 46 capsules of 56 capsules at the end of the study
Intervention groups
Intervention group: Participants in this group follow the weigh loss diet like control group. Calorie intake of participants is calculated base on Harris-Benedict Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + consumption of symbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) microbal population : 1010 CFU/gr and 38/5 mg fructooligosaccharide, once daily for 8 weeks. symbiotic supplement will be purchase from Zist takhmir company. Control group: weight loss diet + placebo
Main outcome variables
Primary outcome: Adiponectin Secondary outcomes: TNF-alpha; hs-CRP; Apo-A1, and Apo-B100

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091114002709N49
Registration date: 2018-05-18, 1397/02/28
Registration timing: prospective

Last update: 2018-05-18, 1397/02/28
Update count: 0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
Farzad Shidfar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2755
Email address
shidfar.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-30, 1397/03/09
Expected recruitment end date
2018-11-30, 1397/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of symbiotic supplement on serum adiponectin, hs-CRP, TNF-α, Apo A1 and Apo-B100 concentration in obese and overweight breast cancer survivors with low calorie diet
Public title
Effect of symbiotic supplement on breast cancer recurrence
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female breast cancer survivors (or Cessation of menstruation for at least 6 months prior to chemotherapy) Age range (50-75) BMI = 25 - 40 Kg/m2 At least one month has passed since the last radiotherapy Complete treatment of stage 1 - 4 breast cancer survivors Type of breast cancer : ER/PR+ and HER2- Willingness to cooperate and sign a written informed consent
Exclusion criteria:
History of Diabetes, acute heart failure, cirrhosis hepatic, acute and chronic renal failure History of autoimmune and infectious disease weight loss diet during the 6 months prior to study Smoking Alcohol consumption Nutrition supplement consumption
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
use of stratified randomization based on BMI (BMI=25-30 and BMI=30-40)
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, major researcher, data collectors were kept blind to study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Martyr Hemmat Highway, the highway of Sheikh Fazlullah Nuri and martyr Chamran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-04-20, 1397/01/31
Ethics committee reference number
IR.IUMS.REC1397.32557

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Adiponectin
Timepoint
Before intervention and 8 weeks after the start of intervention
Method of measurement
Elisa method

Secondary outcomes

1

Description
Tumor Necrosis Factor alpha (TNF-α)
Timepoint
Before intervention and 8 weeks after the start of intervention
Method of measurement
Elisa method

2

Description
high-sensitivity C-reactive protein (hs-CRP)
Timepoint
Before intervention and 8 weeks after the start of intervention
Method of measurement
Elisa method

3

Description
Apolipoprotein-A1 (Apo-A1)
Timepoint
Before intervention and 8 weeks after the start of intervention
Method of measurement
Elisa method

4

Description
Apolipoprotein-B100 (Apo-B100)
Timepoint
Before intervention and 8 weeks after the start of intervention
Method of measurement
Elisa method

Intervention groups

1

Description
Intervention group: Intervention group: Weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Participants in both; intervention and control groups refer to the dietitian in the doctor najafi's clinic one time every four weeks to change their diet. Calorie intake of participants is calculated base on Harris-Benedict Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + consumption of symbiotic supplement consists of (Lactobacillus casei, Lactobacillus Rhamnosus, Lactobacillus Bulgaricus, Bifidobacterium breve, Bifidobacterium langum, Streptococcus thermophilus + Fructooligosacharide) microbal population : 1010 CFU/gr and 38/5 mg fructooligosaccharide, once daily for 8 weeks. symbiotic supplement will be purchase from Zist takhmir company.
Category
Treatment - Drugs

2

Description
Control group : weight loss diet consultation (At the beginning of the study all the participants, according to their age, height, weight and calculating Energy Expenditure , should follow the weight loss diet which results in reduction in body weight about 0.5 to 1 kg per week. Participants in both; intervention and control groups refer to the dietitian in the doctor najafi's clinic one time every four weeks to change their diet. Calorie intake of participants is calculated based on Harris-Benedict Formula. The recommended amount of calories from each nutrient during the day will be based on : carbohydrates 65-55%, fat 35-20% and protein 15-10% of the calories) + placebo consists of ( lactose,Magnesium Stearate, talk, silicon dioxide) once daily for 8 weeks. Placebo will be purchase from Zist takhmir company.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Safa Najafi Clinic
Full name of responsible person
Dr Safa Najafi
Street address
Doctor's building number 3, unit 11, Molasadra Street, Vanak Square
City
Tehran
Province
Tehran
Postal code
1234561
Phone
+98 21 4401 3375
Email
rajimahsa@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor seyed Javad ali Mosavai
Street address
Martyr Hemmat Highway, the highway of Sheikh Fazlullah Nuri and martyr Chamran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
rajimahsa@yahoo.com
Grant name
Grant Masters Selected Research Week
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Raji Lahiji
Position
Student / Nutrition master
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Martyr Hemmat Highway, the Highway of Sheikh Fazullah Nuri and martyr Chamran, School of public health , nutrition group
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 4401 3375
Email
Rajimahsa@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor Mitra Zarrati
Position
PHD nutrition/ Science committee of Nutrition group
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Martyr Hemmat Highway, the highway of Sheikh Fazlullah Nuri and martyr Chamran, school of public health, nutrition group
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4814
Email
zarrati-ms@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Raji Lahiji
Position
Student / Nutrition master
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Martyr Hemmat Highway, the Highway of Sheikh Fazullah Nuri and martyr Chamran, School of public health , nutrition group
City
Tehran
Province
Tehran
Postal code
۸۶۷۰۱-۰۲۱
Phone
+98 21 4401 3375
Email
rajimahsa95@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
participants privacy security
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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