Present study has been conducted to determine effect of probiotics on inflammation factors of patients with type II diabetes mellitus.
Methods:This double-blind randomized, clinical trial study will be done on 44 type-2 diabetic patients, by available sampling. Patients were allocated to either case or control groups by permuted block randomization. Case group will receive one probiotic tablet and control group receive one placebo tablet daily for 8 weeks. At baseline and the end of study, 5 ml blood will be collected from each patient after a 14-h fasting in order to determine inflammation factors (CRP, TNF-α, IL-6) and serum lipid profile level. Dietary intake, anthropometric indices, blood pressure also were measured at baseline and the end of study. Data were analyzed by descriptive and analytic statistics.
This study will show that probiotic supplementation is probably effective in risk factors for cardiovascular diseases in type 2 diabetes, via effect on serum lipid profile and inflammation factors.
The effects of pro-biotic on inflammation factors in patients with type 2 diabetes mellitus
Public title
Pro-biotic on inflammation factors in patients with type 2 diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients affected to diabetes melitus type 2; body mass index <35 kg/m2; patients enrolled in this study should have no infectious disease, hepatitis or renal diseases.
Exclusion criteria: patients received cholesterol-lowering drugs, probiotic, prebiotic and omega-3 fatty acids and antibiotics from 1 month before and during the study.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences- Sabzevar- Khorasan Razavi-
City
Sabzevar
Postal code
Approval date
2011-10-23, 1390/08/01
Ethics committee reference number
122.1696
Health conditions studied
1
Description of health condition studied
Type II diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Inflammation factors (CRP, IL-6 and TNF)
Timepoint
Baseline (before initiating intervention) and 8 weeks after initiating intervention
Kits of Pars Test company and Auto analyzer Selectra 2 methods
Intervention groups
1
Description
supplementation tablet probiotic in intervention group: Each probiotic tablet is comprised of 100 mg Lactol probiotic. Lactol probiotic include Lactobacillus coagulans and Fructooligosaccharides (FOS). Lactol probitic is a product made by Bioplus Company of India which is under licence of Nature's American Company.
Category
Treatment - Drugs
2
Description
placebo in control group: Each placebo tablet contained farina. Placebo tablets were produced by Pharmaceutics department of Mashhad School of Pharmacy.