Effects of synbiotic supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
Objective: The aim of this study is to determine the effects of synbiotic supplementation on carotid intima media thickness (CIMT), metabolic profiles, inflammatory factors and biomarkers of oxidative stress among type 2 diabetes patients with coronary heart disease (CHD). Study design: Parallel double-blind randomized controlled clinical trial. Inclusion and Exclusion Criteria: Invituals aged 45-75 years diagnosed with type 2 diabetes and CHD will be included in this study. Individuals with neurological and physical problems such as kidney disease coupled with heart disease, patients in addition with heart disease facing chronic pain from reins, rheumatism Etc and patients who were used from psychiatric drugs simultaneously will be excluded in the study. Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei(2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and inulin (800 mg) (intervention group: n=30) or placebo (control group: n=30). CIMT will be determined at baseline and after 12-wk intervention. Fasting blood samples will be taken at baseline and after 12-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 12 weeks (March 20, 2015-June 21, 2015). Outcomes: Fasting plasma glucose (FPG), serum insulin, lipid profiles, inflammatory factors and biomarkers of oxidative stress will be measured at baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201503025623N37
Registration date:2015-03-10, 1393/12/19
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-03-10, 1393/12/19
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-03-15, 1393/12/24
Expected recruitment end date
2015-03-19, 1393/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of synbiotic supplementation on carotid intima media thickness (CIMT) and metabolic profiles among type 2 diabetes patients with coronary heart disease
Public title
Effect of supplementation in treatment of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Subjects aged 45-75 years; diagnosed with type 2 diabetes and CHD.
Exclusion Criteria: Patients with neurological and physical problems such as kidney disease coupled with heart disease; patients in addition with heart disease facing chronic pain from reins, rheumatism Etc; patients who were used from psychiatric drugs simultaneously.
Age
From 45 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2015-03-01, 1393/12/10
Ethics committee reference number
93209
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.9
ICD-10 code description
Ischaemic heart disease (chronic)
Primary outcomes
1
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
3
Description
Cholesterol
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
4
Description
Triglyceride
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
5
Description
Total antioxidant capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
6
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
7
Description
Nitric oxide
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
8
Description
Carotid intima media thickness
Timepoint
Baseline and End-of-trial
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Synbiotic capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei(2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and inulin (800 mg), daily, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule, daily, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
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
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
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir- asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
asemi_z@kaums.ac.ir- asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)