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Effects of Lactobacillus rhamnosus supplementation on inflammatory and oxidative biomarkers, gut microbiota profile, gut metabolites and cardiac remodeling in patients with Myocardial Infarction (MI)

Protocol summary

Study aim
To determine whether weight loss diet with or without Lactobacillus rhamnosus supplementation on inflammatory and oxidative biomarkers, gut microbiota profile, gut metabolites and cardiac remodeling in patients with Myocardial Infarction (MI).
Design
Randomized double-blind clinical trial with two arm parallel groups phase 3 trial
Settings and conduct
The trial will be conducted at outpatient cardiology clinic of Shahid Madani Heart center affiliated to Tabriz University of Medical Sciences, Iran. All the patients will be screened by an expert cardiologist for eligibility. Those willing to take part in the study will be carefully evaluated with reference to inclusion criteria. Then, they will be requested to sign an informed consent. A third party who is blind to the study will give the sequence extracted from allocation software. After an overnight fasting, blood will be collected and supplements will be provided to the participants. supplementation duration will be 12 weeks.
Participants/Inclusion and exclusion criteria
forty eight patients with Myocardial Infarction (MI) will be included in the study. Subjects with diabetes; chronic renal failure and history of supplementation with prebiotics will not be included.
Intervention groups
The subjects in both groups will receive a weight loss diet. Patients in the intervention group will use a Lactobacillus rhamnosus capsules 1.6 ×109 with their lunch, daily. In the placebo (control) group, the capsules will contain of maltodextrin.
Main outcome variables
Physical activity level, Depression level, Quality of Life, echocardiography in terms of cardiac remodeling,, serum levels of antioxidant capacity, lipid profile, inflammatory markers,gut microbiota profile and gut metabolite

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121028011288N15
Registration date: 2018-06-27, 1397/04/06
Registration timing: registered_while_recruiting

Last update: 2018-06-27, 1397/04/06
Update count: 0
Registration date
2018-06-27, 1397/04/06
Registrant information
Name
Mohammad Alizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7313
Email address
mdalizadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Lactobacillus rhamnosus supplementation on inflammatory and oxidative biomarkers, gut microbiota profile, gut metabolites and cardiac remodeling in patients with Myocardial Infarction (MI)
Public title
The Effects of Lactobacillus rhamnosus in patients with Myocardial Infarction (MI)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Myocardial Infarction and successful precancerous intervention (PCI) age range from 30-60 years body mass index (BMI) higher than 25 kg/m2 will be included in the study.
Exclusion criteria:
patient with chronic renal failure; hemodialysis previous myocardial infraction patients receiving immunosuppressive, anti-inflammatory and corticosteroid drugs; history of supplementation with pre/pro/symbiotic or antioxidants during previous two months will not be included in the study. with Being irritable bowel syndrome; Crohn's disease or ulcerative colitis Heart failure (functionclass III and IV), Heart valve diseases Subjects with diabetes
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the Lactobacillus rhamnosus capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company (Takgene Company).
Placebo
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
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2018-05-21, 1397/02/31
Ethics committee reference number
IR.TBZMED.REC.1397.184

Health conditions studied

1

Description of health condition studied
Myocardial Infarction (MI)
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
Depression severity
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Beck Depression Inventory scale

2

Description
Physical activity level
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Via IPAQ questionnaire

3

Description
Quality of life
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Via MacNew questionnaire

4

Description
Lipid profile including HDL, LDL, TC and TG
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
HDL, TC and TG via enzymatic kit, LDL via friedewald equation

5

Description
Serum levels of Gut metabolites (TLR4, Zonulin and LPS)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
TLR4, Zonulin and LPS measurements by ELISA

6

Description
Oxidative stress indices
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) by spectrophotometry

7

Description
Serum level of Gut metabolite ( TMAO)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
TMAO level by MS / MS

8

Description
Inflammatory stress indices
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of inflammatory indices of hs-CRP, IL1B and IL-10 in serum by ELISA

9

Description
Level of ox-LDL
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of ox-LDL via ELISA kit

10

Description
Levels of TGF. Beta
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of TGF. Beta via ELISA kit

11

Description
Levels of NTpro BNP
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of NTpro BNP via ELISA kit

12

Description
Levels of MMP-9
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of NTpro BNP via ELISA kit

13

Description
Levels of Procolagen I
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Measurement of Procolagen I via ELISA kit

14

Description
Echocardiographic indices of cardiac remodeling including left ventricular end diastolic diameter (LVEDD), right ventricular end diastolic diameter (RVEDD), left ventricular end-diastolic volume (LVEDV), right ventricular end-diastolic volume (RVEDV) and Ejection Fraction ( EF)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
3-Dimentional Echocardiography

Secondary outcomes

1

Description
dietary inflammatory index (DII )
Timepoint
At the beginning of the study and 12 weeks later
Method of measurement
via Food Frequency Questionnaire

Intervention groups

1

Description
Intervention group: Patients in this group will receive probiotic capsule for 12 weeks. Probiotic capsule is a containing 1.6× 109 CFU of lactobacillus rhamnosus (a product by TacZist Co. and made in The Iran) and used once a day with lunch.
Category
Treatment - Drugs

2

Description
Control group:Patients in this group will receive maltodextrin capsules for 12 weeks which are same size and shape ( product by TacZist Co. and made in The Iran) and used once a day with lunch.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Medical Research Training Center
Full name of responsible person
Dr. Mohammad Alizadeh
Street address
Daneshgah street, Shahid Madani Medical Research Training Center
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
mdalizadeh@tbzmed.ac.ir
Web page address
http://nutr.tbzmed.ac.ir/?PageID=128&ID=37&BasesID=140

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Juyban
Street address
Vice Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
mdalizadeh@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
Ph.D. candidate of nutrition sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3381 1902
Fax
+98 41 3334 0634
Email
jmoludi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Alizadeh
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
mdalizadeh@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Alizadeh
Position
Superviser, Professor, Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street, Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1335 7313
Fax
+98 41 1334 4731
Email
mdalizadeh@tbzmed.ac.ir
Web page address
http://www.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Accessibility to data is possible 8 months after publication.
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta analysis.
From where data/document is obtainable
1. Dr. Mohammad Alizadeh, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, +989141894102, mdalizadeh@tbzmed.ac.ir 2. Jalal Moludi, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, +989399516760, jmoludi@yahoo.com
What processes are involved for a request to access data/document
The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person.
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