The effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic nephropathy
Objective: The aim of this study is to determine the effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic nephropathy. Study design: Randomized double-blinded cross-over controlled clinical trial. Inclusion Criteria: Patients with diabetic nephropathy with FPG ≥ 126 mg/dl, less than 15 years of their disease and aged 35 to 65 years will be included in this study. Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune) and pregnant or lactating women will be included in this study. Population and sample size: 70 patients with diabetic nephropathy of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either the synbiotic food (intervention group: 35) or control food (control group: 35). Fasting blood samples will be taken at baseline and after 6-wk intervention. A 3-week washout period will be applied. Start and End Date of Intervention: 5 months (January 10, 2013-June 10, 2013). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301195623N5
Registration date:2013-02-23, 1391/12/05
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2013-02-23, 1391/12/05
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Science and Sekkeh Gaz company
Expected recruitment start date
2013-01-10, 1391/10/21
Expected recruitment end date
2013-06-11, 1392/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of a synbiotic food of fortified with beta-carotene on metabolic profiles, inflammatory factor and biomarkers of oxidative stress in patients with diabetic nephropathy
Public title
The effects of a synbiotic food of fortified with beta-carotene in the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diabetic nephropathy with FPG ≥ 126 mg/dl; less than 15 years of their disease; aged 35 to 65 years.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with chronic kidney disease; liver; lung; chronic or acute inflammatory diseases; heart valve disease; short bowel syndrome and allergies; patients with low immune system ability (autoimmune); pregnant; lactating.
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Science
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2013-02-11, 1391/11/23
Ethics committee reference number
29/5/1/4138/پ
Health conditions studied
1
Description of health condition studied
diabetes- cardiovascular
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
FPG
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
2
Description
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
3
Description
hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
4
Description
Total Antioxidant Capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
5
Description
Total Glutathione
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Probiotic viable and heat-resistance strain Lactobacillus sporogenes (108 CFU), 0.2 g inulin, 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia, 0.05 g beta-carotene per 1 g, 20 g, thrice a day for 6 weeks
Category
Other
2
Description
Control group: 0.38 g isomalt, 0.36 g sorbitol, 0.05 g stevia per 1 g, 20 g, thrice a day for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic
Full name of responsible person
Zatollah Asemi
Street address
Shahid Rajaee Avenue, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
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 Science
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Sekkeh Gaz Company
Full name of responsible person
Sabiheh-Alsadat Alizadeh
Street address
Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sekkeh Gaz Company
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
8719844189
Phone
+98 36 1446 3378
Fax
+98 36 1446 3377
Email
asemi_r@yahoo.comasemi_z@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Science
Full name of responsible person
Zatollah Asemi
Position
PhD Nutrition
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
8719844189
Phone
+98 36 1446 3378
Fax
+98 36 1446 3377
Email
asemi_r@yahoo.comasemi_z2kaums.as.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)