Protocol summary
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Study aim
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If appropriate, it is recommended to use probiotic yogurt in the diet of patients with type 2 diabetes with nephropathy
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Design
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Controlled, parallel, double-blind clinical trial, people with diabetic nephropathy, 60 people; randomization by rand function of Excel software
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Settings and conduct
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Controlled, parallel, double-blind clinical trial, in Imam Khomeini Hospital Diabetes Clinic, before the intervention, anthropometric assessments, glycemic indexes, renal indices, blood lipid indices, inflammatory markers and blood pressure indices in all individuals are assessed. The software will randomly divide participants into intervention and control groups; intervention: 300 g daily probiotic yogurt for 8 weeks, control: 300 g normal yogurt daily for 8 weeks. The yogurts have the same color, shape, taste and smell are used so that the researcher and the patient are not aware of its type and only our distributor is aware of its type.
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Participants/Inclusion and exclusion criteria
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Inclusion:
Diabetic nephropathy with microalbuminuria (Albumin to creatinine ratio 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2), age 20 to 80 years, BMI less than 40 kg / m2
Exclusion: History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders other than diabetic nephropathy, smoking and alcohol and tobacco use, history of antibiotics and NSAIDs during a recent month, use Omega-3 supplementation and vitamins E, C during the last three months, taking probiotic supplements or foods containing probiotics during the last three months, lactose intolerance, pregnancy
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Intervention groups
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Intervention: daily 300g probiotic yogurt for 8 weeks, control: 300g normal yogurt for 8 weeks
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Main outcome variables
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eGFR; Albumin to creatinine ratio; Urea; Creatinine; Serum uric acid; Systolic and diastolic blood pressure; TG; TC; LDL; HDL; HbA1c; Fasting blood sugar; hs-CRP; Weight; Waist; BMI
General information
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Reason for update
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Replacement of albumin to creatinine ratio index due to newer, higher accuracy and ease of measurement
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20201125049491N1
Registration date:
2020-12-28, 1399/10/08
Registration timing:
prospective
Last update:
2022-02-14, 1400/11/25
Update count:
2
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Registration date
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2020-12-28, 1399/10/08
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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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2021-11-11, 1400/08/20
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Expected recruitment end date
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2021-12-11, 1400/09/20
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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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The effect of daily consumption of probiotic yogurt on albumin to creatinine Ratio, eGFR and metabolic parameters in type 2 diabetic patients with microalbuminuria
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Public title
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The effect of daily consumption of probiotic yogurt on albumin to creatinine Ratio, eGFR and metabolic parameters in type 2 diabetic patients with microalbuminuria
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diabetic nephropathy with microalbuminuria (Albumin to creatinine ratio 30-299 mg / g Cr, eGFR≥ 30 ml / min / 1.73m2)
Has an age of 80-20 years
BMI less than 40 kg / m2
Exclusion criteria:
History of chronic diseases including: IBD, liver disease, rheumatoid arthritis, renal disorders except diabetic nephropathy
Smoking, alcohol and tobacco
History of taking antibiotics and NSAIDS (during the last month)
Take omega 3 supplements and vitamins E and C during the last three months
Consumption of probiotic supplements or foods containing probiotics during the last three months
Lactose intolerance
Pregnancy
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Age
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From 20 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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N/A
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Groups that have been masked
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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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Each person is assigned a code and this code is entered into Excel software, and then used to randomize the rand function of Excel software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The shape, appearance, packaging, color and smell of both probiotic and non-probiotic yogurts will be quite similar. In addition, the person who provides yogurts to patients is aware of the type of yogurt, but the researcher and the patient are not aware of it.
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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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2020-09-19, 1399/06/29
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.458
Health conditions studied
1
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Description of health condition studied
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Diabetic nephropathy
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ICD-10 code
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E11.21
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ICD-10 code description
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Type 2 diabetes mellitus with diabetic nephropathy
Primary outcomes
1
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Description
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Albumin to creatinine ratio
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Timepoint
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First the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Laboratory kits
Secondary outcomes
1
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Description
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eGFR
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Timepoint
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At the beginning of the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
2
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Description
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TG
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Timepoint
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At the beginning of the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
3
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Description
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TC
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Timepoint
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At the beginning of the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
4
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Description
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LDL
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Timepoint
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At the beginning of the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
5
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Description
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HDL
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Timepoint
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At the beginning of the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
6
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Description
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FBS
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Timepoint
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At the beginning of the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
7
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Description
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HbA1c
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Timepoint
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At the beginning of the intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
8
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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 intervention and 8 weeks later at the end of the intervention
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Method of measurement
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Special laboratory kit
Intervention groups
1
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Description
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Intervention group: They will receive 300g of probiotic yogurt(Haraz Company) enriched with Bifidobacterium lactis and Lactobacillus acidophilus strains daily for 8 weeks. Microbiological analyzes showed that the average colony content of both strains is 10 ^ 6 CFU / g.
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Category
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Rehabilitation
2
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Description
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Control group: Control group: 300g will receive normal yogurt from Haraz company for 8 weeks
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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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No
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Title of funding source
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Diabetes Research Center, Research Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences
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Proportion provided by this source
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40
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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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no more information
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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