IRCT | Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease

#	Registration date	Revision Id
4	2019-10-10, 1398/07/18	107155
3	2019-09-15, 1398/06/24	103931
2	2018-03-30, 1397/01/10	41701
1	2017-09-07, 1396/06/16	26047

Protocol summary

Study aim: Objective: The aim of this study is to determine the effects of probiotic supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD)
Design: Study design: Randomized double-blind placebo-controlled trial. Randomization will be done by the use of computer-generated random numbers. Patients will be assigned into two groups to receive probiotic supplement (n=30) or placebo (n=30).
Settings and conduct: Among patients with type 2 diabetes and coronary heart disease referred to Cardiology Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Patients with type 2 diabetes and coronary heart disease aged 40 to 85 years. Exclusion criteria: Consuming probiotic and/or synbiotic within three months prior to the intervention, taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids, taking antibiotics, having an acute myocardial infarction and a cardiac surgery in the past three months, renal or hepatic failure.
Intervention groups: Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally. Control group: Placebo capsule (Barij essence, Kashan, Iran), daily, for 12 weeks orally.
Main outcome variables: Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (secondary outcome) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT2017082733941N5

Registration date: 2017-09-07, 1396/06/16

Registration timing: retrospective

Last update: 2019-09-17, 1398/06/26

Update count: 3
Registration date: 2017-09-07, 1396/06/16

Registrant information: Name

Mohammadreza Sharif

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 31 5546 3378

Email address

ostadmohammadi-vr@kaums.ac.ir

Recruitment status: Recruitment complete
Funding source: Vice chancellor for research, Kashan University of Medical Sciences

Expected recruitment start date: 2017-08-17, 1396/05/26
Expected recruitment end date: 2017-09-02, 1396/06/11
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease

Public title: Effect of probiotic supplementation in treatment of coronary heart disease
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Subjects aged 45-85 years Patients diagnosed with type 2 diabetes and coronary heart disease

Exclusion criteria:

Consuming probiotic and/or synbiotic within three months prior to the intervention Taking prebiotic, antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids Taking antibiotics Having an acute myocardial infarction and a cardiac surgery in the past three months Renal or hepatic failure
Age: From 40 years old to 85 years old
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Investigator
Outcome assessor

Sample size

Target sample size: 60

Randomization (investigator's opinion)

Randomized

Randomization description

Randomization will be done by the use of computer-generated random numbers.

Blinding (investigator's opinion)

Double blinded

Blinding description

Participants, investigators or the assessors of the outcomes are unaware of the study groups.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Kashan University of Medical Sciences

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

8115187159
Approval date: 2017-08-16, 1396/05/25
Ethics committee reference number: IR.KAUMS.MEDNT.REC.1396.37

Health conditions studied

1

Description of health condition studied: Coronary Heart Disease
ICD-10 code: I25.9
ICD-10 code description: Chronic ischaemic heart disease, unspecified

Primary outcomes

1

Description: Insulin
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Elisa kit

2

Description: Insulin resistance
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Calculation using HOMA formula

Secondary outcomes

1

Description: Triglycerides
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Enzymatic kit

2

Description: Total cholesterol
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Enzymatic kit

3

Description: HDL
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Enzymatic kit

4

Description: Hs-CRP
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Elisa kit

5

Description: Nitric oxide
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Spectrophotometry

6

Description: Malondialdehyde
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Spectrophotometry

7

Description: Glutathione
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Spectrophotometry

8

Description: Total antioxidant capacity
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Spectrophotometry

9

Description: Systolic blood pressure
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Manometer

10

Description: Diastolic blood pressure
Timepoint: At the beginning of the study and after 12 weeks of intervention
Method of measurement: Manometer

Intervention groups

1

Description: Intervention group: Probiotic supplements containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g), daily, for 12 weeks orally.
Category: Treatment - Drugs

2

Description: Control group: Placebo capsule (Tak Gen Zist Pharmaceutical Company, Tehran, Iran), daily, for 12 weeks orally.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Naghavi cardiology Clinic

Full name of responsible person

Zatollah Asemi

Street address

Shahid Rajaee Avenue, Kashan

City

Kashan

Province

Isfehan

Postal code

8115187159

Phone

+98 31 5546 3378

Email

asemi_z@kaums.ac.ir

1

Sponsor: Name of organization / entity

Kashan University of Medical Sciences

Full name of responsible person

Gholamali Hamidi

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

8115187159

Phone

+98 31 5546 3378

Email

Hamidi_gh@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Kashan 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

Kashan University of Medical Sciences

Full name of responsible person

Zatollah Asemi

Position

Ph.D of Nutrition

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

8115187159

Phone

+98 31 5546 3378

Fax

Email

asemi_z@kaums.ac.ir

Web page address

Person responsible for scientific inquiries

Contact: Name of organization / entity

Kashan University of Medical Sciences

Full name of responsible person

Zatollah Asemi

Position

Ph.D of Nutrition

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

8115187159

Phone

+98 31 5546 3378

Fax

Email

asemi_z@kaums.ac.ir

Web page address

Person responsible for updating data

Contact: Name of organization / entity

Kashan University of Medical Sciences

Full name of responsible person

Zatollah Asemi

Position

Ph.D of Nutrition

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

Ghotbe Ravandi Boulevard, Kashan

City

Kashan

Province

Isfehan

Postal code

8115187159

Phone

+98 31 5546 3378

Fax

Email

asemi_z@kaums.ac.ir

Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be a plan to make this available
Study Protocol: Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan: Undecided - It is not yet known if there will be 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

Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease

Help:

Protocol summary

General information

Secondary outcomes

#1

#2

Intervention groups

#1

Recruitment centers

#1

Sharing plan

Protocol summary

General information

Secondary Ids

Ethics committees

1

Health conditions studied

1

Primary outcomes

1

2

Secondary outcomes

1

2

3

4

5

6

7

8

9

10

Intervention groups

1

2

Recruitment centers

1

Sponsors / Funding sources

1

Person responsible for general inquiries

Person responsible for scientific inquiries

Person responsible for updating data

Sharing plan