Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of combined probiotic and selenium supplementation on metabolic profiles in type 2 diabetic patients with coronary heart disease (CHD).
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Design
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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 combined probiotic and selenium supplements (n=30) or placebo (n=30).
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Settings and conduct
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Among patients with CHD referred to Naghavi outpatient 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. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Individuals aged 45-85 years diagnosed with type 2 diabetes and CHD will be included in this study. Exclusion criteria: Selenium, probiotic and/or synbiotic consumption within the last 3 months, patients with thyroid disorders, severe renal insufficiency and hepatic failure, experiencing an acute myocardial infarction and cardiac surgery within the past 3 months .
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Intervention groups
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Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and selenium supplements (Webber Naturals, Coquitlam, Canada), 200 µg, daily, for 12 weeks orally.
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Main outcome variables
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Outcomes: Insulin resistance (primary outcomes) and other metabolic profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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correction
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170513033941N28
Registration date:
2018-01-18, 1396/10/28
Registration timing:
retrospective
Last update:
2019-10-28, 1398/08/06
Update count:
2
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Registration date
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2018-01-18, 1396/10/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-12-29, 1396/10/08
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Expected recruitment end date
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2018-01-15, 1396/10/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on metabolic profiles in type 2 diabetic patients with coronary heart disease
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Public title
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Effect of combined probiotic and selenium supplementation in treatment of coronary heart disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Inclusion Criteria: patients diagnosed with type 2 diabetes and coronary heart disease.
Individuals aged 45-85 years.
Exclusion criteria:
Exclusion Criteria: Selenium, probiotic and/or synbiotic consumption within the last 3 months
Patients with thyroid disorders
Severe renal insufficiency and hepatic failure
Experiencing an acute myocardial infarction and cardiac surgery within the past 3 months
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Age
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From 45 years old to 85 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At first, all participants were categorized according to age and pre-intervention BMI. Then, patients were randomly allocated into two groups to take either supplements or placebo. Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-28, 1396/10/07
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Ethics committee reference number
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IR.KAUMS.REC.1396.62
Health conditions studied
1
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Description of health condition studied
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Coronary Heart Disease
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ICD-10 code
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I25.9
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ICD-10 code description
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Chronic ischemic heart disease, unspecified
Primary outcomes
1
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Secondary outcomes
1
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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HDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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Hs-CRP
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
5
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
10
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Description
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Beck Depression Inventory
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
11
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Description
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Beck Anxiety Inventory
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
12
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Description
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Pittsburgh Sleep Quality Index
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Questionnaire
13
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Description
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Systolic blood pressure
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Manometer
14
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Description
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Diastolic blood pressure
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Manometer
Intervention groups
1
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Description
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Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and selenium supplements (Webber Naturals, Coquitlam, Canada), 200 µg, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij essence, Kashan, Iran), daily, for 12 weeks orally.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available