Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of probiotic honey supplementation on metabolic profiles including insulin resistance and lipid profiles in patients with diabetic nephropathy.
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Design
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Randomized, double-blind, placebo-controlled clinical trial, phase 3, 60 patients
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Settings and conduct
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60 patients with diabetic nephropathy of eligible and referred to Akhavan Clinic, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Patients with diabetic nephropathy with a proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels and aged 45 to 85 years will be included in this study. Exclusion criteria: History of active infection within 3 months, the intake of probiotic and/or synbiotic supplements within 3 months and malignancy and/or liver cirrhosis.
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Intervention groups
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Intervention: Patients will be assigned to receive either probiotic honey (n=30) or control honey (n=30). Probiotic and control honey are similar in shape and size.
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Main outcome variables
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Outcomes: Insulin metabolism parameters (primary outcomes) and lipid profiles (secondry 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:
IRCT201705035623N115
Registration date:
2017-05-29, 1396/03/08
Registration timing:
retrospective
Last update:
2019-09-22, 1398/06/31
Update count:
1
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Registration date
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2017-05-29, 1396/03/08
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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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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-03-21, 1396/01/01
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Expected recruitment end date
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2017-05-20, 1396/02/30
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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 probiotic honey supplementation compared with the control honey on metabolic profiles in patients with diabetic nephropathy
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Public title
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Effect of supplementation in treatment of patients with diabetic nephropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with diabetic nephropathy
Aged 40 to 80 years
Proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels
Exclusion criteria:
History of active infection within 3 months
The intake of probiotic and/or synbiotic supplements within 3 months
Malignancy and/or liver cirrhosis
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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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To decrease potential confounding effects, after balanced blocked randomisation, all participants will have allocated into two treatment groups to take either probiotic honey or normal honey. Randomization will be done by the use of Stat Trek 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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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Akhavan Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2017-03-07, 1395/12/17
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Ethics committee reference number
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IR.KAUMS.REC.1395.152
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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N08.3
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ICD-10 code description
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Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+)
Primary outcomes
1
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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
2
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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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Questionnaire
Secondary outcomes
1
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Description
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Total antioxidant
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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
2
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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
3
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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
4
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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
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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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
7
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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
8
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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
9
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Description
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FPG
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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
10
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Description
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LDL
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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
Intervention groups
1
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Description
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Control group: 25 g control honey (Sekkeh Gaz, Isfahan, Iran), once a day, 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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Intervention group: 25 g probiotic honey (Sekkeh Gaz, Isfahan, Iran), 108 Lactobacillus sporogenes CFU/g, once a day, for 12 weeks orally.
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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