Protocol summary
-
Study aim
-
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).
-
Design
-
Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers.
-
Settings and conduct
-
Population and sample size: 60 type 2 diabetes patients with CHD eligible and referred to Naghavi cardiology Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
-
Participants/Inclusion and exclusion criteria
-
Inclusion Criteria: Subjects aged 40-85 years diagnosed with type 2 diabetes and CHD. Exclusion Criteria: Consuming synbiotics and/or probiotics supplements within the past 3 months, changes in the dosage and kind of medications, taking anti-inflammatory drugs, having an myocardial infarction within the past 3 months, having cardiac surgery within the past 3 months, significant renal and hepatic failure.
-
Intervention groups
-
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.
Control group: Placebo capsule, daily, for 12 weeks orally.
-
Main outcome variables
-
Outcomes: Biomarkers of insulin metabolism and CIMT (primary outcomes), and lipid and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT201503025623N37
Registration date:
2015-03-10, 1393/12/19
Registration timing:
registered_while_recruiting
Last update:
2019-10-04, 1398/07/12
Update count:
1
-
Registration date
-
2015-03-10, 1393/12/19
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Kashan University of Medical Sciences
-
Expected recruitment start date
-
2015-03-02, 1393/12/11
-
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 40-85 years diagnosed with type 2 diabetes and CHD
Exclusion criteria:
Consuming synbiotics and/or probiotics supplements within the past 3 months
Changes in the dosage and kind of medications
Taking anti-inflammatory drugs
Having an myocardial infarction within the past 3 months
Having cardiac surgery within the past 3 months
Significant renal and hepatic failure
-
Age
-
From 40 years old to 85 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take supplements (n = 30) or placebo (n = 30). 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
-
Ethics committees
1
-
Ethics committee
-
-
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
-
Insulin
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa
2
-
Description
-
Carotid intima media thickness
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Sonography
3
-
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
-
Fasting plasma sugar
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
2
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
3
-
Description
-
HDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
4
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
5
-
Description
-
Hs-CRP
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
6
-
Description
-
Nitric oxide
-
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
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
1
-
Sponsor
-
-
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
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