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The effect of supplementation synbiotic (probiotic bacteria Lactobacillus plantarum with chicory root extract) on antioxidant and inflammatory markers in overweight diabetics

Protocol summary

Summary
The aim of this study is to evaluate the effect of Lactobacillus plantarum with chicory root extract on antioxidant and inflammatory markers in overweight diabetic patients referred to the Research Center of Metabolic Disorders. This randomized controlled trial consists of 100 overweight diabetic patients, inclusions criteria: high blood sugar over 100 mg per dL, body mass index over 25 kg / m2, the age between 20 and 75 years. After determining the population under study, patients were randomly divided into 4 groups : Symbiotic group: this group will receive a capsule containing Lactobacillus plantarum 108 cfu/ml and 2 g chicory root extract for 90 days, probiotics group: this group will receive a capsule containing Lactobacillus plantarum 108 cfu/ml, prebiotic group: this group will receive a capsule containing 2 grams chicory root extract and finally, control group: this group will received a capsule containing 2 grams of rice flour. At the end of the study to assess the inflammation, white blood cell count, hCRP, adiponectin and leptin, and to evaluate the antioxidant status, malondialdehyde and paraoxonase activity will be measured in the serum of patients will be measured. The results of each group will be compared with control and statistically analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062628386N2
Registration date: 2016-08-02, 1395/05/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-02, 1395/05/12
Registrant information
Name
Mahboobeh Mehrabani Natanzi
Name of organization / entity
Alborz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3433 6008
Email address
mahboobehmehrabani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Alborz University of Medical SciencesandMetabolic Disorders Research Center of Tehran University Of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2018-01-21, 1396/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supplementation synbiotic (probiotic bacteria Lactobacillus plantarum with chicory root extract) on antioxidant and inflammatory markers in overweight diabetics
Public title
The effect of synbiotic supplement on improvement of diabetics overweight status.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: High blood glucose over 100 mg per deciliter, 20 to 75 years of age, voluntary consent for participation in the study Exclusion criteria: A special diet (such as weight loss diet) in the previous three months of the study and during the study,patients with cancer, uncontrolled diabetes, acute infectious diseases, mental illness or any other illness that can potentially rapid decline weight, person with chronic gastrointestinal disease, using systemic antibiotic 6 weeks before entering the study, using probiotics and omega-3 supplements in the previous three months of the study, identified immunodeficiency, pregnancy or breastfeeding, Participation in other clinical trials in the last 6 months.
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Alborz University of Medical Sciences
Street address
Faculty of medicine, Golestan 1, Eshteraki, Baghestan, Karaj
City
Karaj
Postal code
Approval date
2016-05-25, 1395/03/05
Ethics committee reference number
Abzums.Rec.1395.1

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Antioxidant biomarkers
Timepoint
3 months after intervention
Method of measurement
MDA concentration and PON activity in serum

2

Description
Inflammatory markers
Timepoint
3 months after intervention
Method of measurement
WBC counts, Leptin and Adiponectin concentration in serum and blood

3

Description
Fasting blood Glucose
Timepoint
At starting of the study and 3 months after intervention
Method of measurement
autoanalyzer

4

Description
Lipid profile
Timepoint
3 months after intervention
Method of measurement
autoanalyzer

Secondary outcomes

1

Description
weight
Timepoint
At starting of the study and after 3 months
Method of measurement
Scale

2

Description
Body mass index
Timepoint
At starting of the study and after 3 months
Method of measurement
Weight(Kg)/height(m2)

Intervention groups

1

Description
Intervention Group 1: Chicorium intybus. L powder 600 mg with probiotic bacteria L.plantarum 108 cfu/ml in capsule daily for 3 months
Category
Treatment - Drugs

2

Description
Intervention Group 2: Probiotic bacteria L.plantarum 108 cfu/ml in capsule daily for 3 months
Category
Treatment - Drugs

3

Description
Intervention Group 3: Chicorium intybus. L powder 600 mg in capsule daily for 3 months
Category
Treatment - Drugs

4

Description
Control Group: Two grams of rice flour in capsule daily for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes & Metabolic Diseases Clinic of Tehran University Of Medical Sciences
Full name of responsible person
Dr Ensieh Nasli
Street address
North Kargar Street, Shahrivar Street, Diabetes & Metabolic Diseases Clinic
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Alborz University of Medical Sciences
Full name of responsible person
Dr Mohammad Javad Gharavi
Street address
Dara Building, East Pooneh, 45 meters Golshahr, Karaj
City
Karaj
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, Alborz University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Metabolic Disorders Research Center of Tehran University Of Medical Sciences
Full name of responsible person
Dr Maryam Razaghi Azar
Street address
North Kargar Street, Shahrivar Street, Diabetes & Metabolic Diseases Clinic
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Metabolic Disorders Research Center of Tehran University Of Medical Sciences
Proportion provided by this source
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
Alborz University of Medical Sciences
Full name of responsible person
Mahboobeh Mehrabani Natanzi
Position
PhD in biochemistry
Other areas of specialty/work
Street address
Faculty of Medicine, Eshteraki Blvd. Baghestan, Karaj
City
Karaj
Postal code
Phone
+98 26 3458 4919
Fax
Email
mahboobehmehrabani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Nourbakhsh
Position
PhD in biochemistry
Other areas of specialty/work
Street address
Faculty of Medicine, Iran university of Medical Sciences, Otoban hemat, Tehran
City
Tehran
Postal code
Phone
+98 21 8833 4190
Fax
Email
mitra.nourbakhsh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Alborz University of Medical Sciences
Full name of responsible person
Khaterh Amini
Position
MSC of food industry
Other areas of specialty/work
Street address
Dara Building, East Pooneh, 45 meters Golshahr, Karaj
City
Karaj
Postal code
Phone
+98 26 3458 4919
Fax
Email
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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