Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of synbiotic supplementation on metabolic profiles in diabetic hemodialysis patients.
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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 supplement (n=30) or placebo (n=30).
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Settings and conduct
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Among diabetic hemodialysis patients referred to Akhavan Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran, 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: diabetic hemodialysis patients; aged 18 to 80 years. Exclusion criteria:Taking probiotic and/or synbiotic supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment, required changes in medications during the study and recent diabetes diagnosis.
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Intervention groups
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Intervention group: Synbiotic oral capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (Tak Gen Zist, Tehran, Iran), 0.8 g inulin, daily, for 12 weeks. Control group: Placebo oral capsule (Tak Gen Zist, Tehran, Iran), daily, for 12 weeks.
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Main outcome variables
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Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles, biomarkers of inflammation and oxidative stress (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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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017090133941N17
Registration date:
2017-11-01, 1396/08/10
Registration timing:
registered_while_recruiting
Last update:
2019-09-16, 1398/06/25
Update count:
1
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Registration date
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2017-11-01, 1396/08/10
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-11-01, 1396/08/10
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Expected recruitment end date
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2017-11-15, 1396/08/24
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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 synbiotic supplementation compared with the placebo on metabolic profiles in diabetic hemodialysis patients
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Public title
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Effect of synbiotic supplementation in treatment of diabetic hemodialysis patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diabetic hemodialysis patients
Aged 18 to 80 years
Exclusion criteria:
Taking probiotic and/or synbiotic supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to the enrollment
Required changes in medications during the study and recent diabetes diagnosis
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Age
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From 18 years old to 80 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 study baseline and after stratification for pre-intervention BMI (<25 and ≥25 kg/m2) and age (<50 and ≥50 y), subjects will be randomly divided into two groups to receive supplement 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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2017-10-12, 1396/07/20
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.44
Health conditions studied
1
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Description of health condition studied
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Hemodialysis
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ICD-10 code
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N18
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ICD-10 code description
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Chronic kidney disease
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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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
2
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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
3
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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
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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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
7
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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
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
Intervention groups
1
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Description
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Intervention group: Synbiotic oral capsule containing three strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g) and Bifidobacterium bifidum (2×109 CFU/g) (Tak Gen Zist, Tehran, Iran), 0.8 g inulin, daily, for 12 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo oral capsule (Tak Gen Zist, Tehran, Iran), daily, for 12 weeks.
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Category
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Treatment - Drugs
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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Vice chancellor for research, 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