The effects of consumption of Lactobacillus Casei on glycemic factors, and serum sirtuin1 and fetuin-A levels in type 2 diabetic patients: A controlled clinical trial.
The aim of present study is evaluating the effect of Lactobacillus Casei on glycemic factors, and serum sirtuin1 and fetuin-A levels in type 2 diabetic patients. In this randomized double blind placebo control study 44 diabetic patient will be selected and randomly assigned into intervention and control groups, each containing 22 subjects. Patients in intervention group will receive probiotic capsules containing 108cfu Lactobacillus Casei and patients in control group will receive placebo capsules daily for 2 months. Inclusion criteria: patients who are diagnosed with type2 diabetes more than a year ago; patients aged 30 to 50 years. Exclusion criteria: Insulin injection, body mass index over 35 kg/m2, infectious and inflammatory diseases, use of antibiotics and anti-inflammatory drugs a month before and/or during intervention.The anthropometric measurements, glycemic factors, and serum sirtuin1 and fetuin-A levels will be measured before and after the intervention. Then the results will be compared and discussed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607034105N17
Registration date:2016-08-14, 1395/05/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-08-14, 1395/05/24
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Department of Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-05, 1395/06/15
Expected recruitment end date
2016-11-05, 1395/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of consumption of Lactobacillus Casei on glycemic factors, and serum sirtuin1 and fetuin-A levels in type 2 diabetic patients: A controlled clinical trial.
Public title
The effects of consumption of Lactobacillus Casei on diabetes control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with diabetes for more than a year of developing diabetes and over 6 months pass the use of glucose lowering drugs ; Age 30 to 50 years. Exclusion criteria: Insulin injections; BMI> 35 Kg / m2; smoking; breastfeeding and pregnancy; menopause; using antibiotics and anti-inflammatory drugs within a month before and during the intervention; chronic digestive problems, and acute gastrointestinal problems within a month before and during the intervention; infectious and inflammatory diseases; Get any supplements.
Age
From 65 years old to 45 years old
Gender
Both
Phase
N/A
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
Tabriz University of Medical Sciences
Street address
Tabriz/ Azady St./ Ghol-Ghasht Ave.
City
Tabriz
Postal code
5166614711
Approval date
2016-07-25, 1395/05/04
Ethics committee reference number
IR.TBZMED.REC.1395.402
Health conditions studied
1
Description of health condition studied
Diabetes Mallitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
befor intervention and after 2 monthes intervention
Method of measurement
Spectrophotometry
2
Description
HbA1c
Timepoint
befor intervention and after 2 monthes intervention
Method of measurement
Column chromatography
3
Description
Insulin Resistance
Timepoint
befor intervention and after 2 monthes intervention
Method of measurement
homeostasis model (HOMA-IR)
4
Description
Serum Fetuin-A
Timepoint
befor intervention and after 2 monthes intervention
Method of measurement
ELISA technique
5
Description
serum sirtuin1
Timepoint
befor intervention and after 2 monthes intervention
Method of measurement
ELISA technique
Secondary outcomes
1
Description
Height and Weight
Timepoint
Before Intervention and After2 Monthes Intervention
Method of measurement
Digital scale and stadiometer
2
Description
Food Intake
Timepoint
Before Intervention, Middle of the Intervention, and After Intervention
Method of measurement
24-hour dietary recalls questionnaire
Intervention groups
1
Description
Placebo capsules
Patients in control group will receive placebo capsules daily for two months.
Category
Placebo
2
Description
Probiotic Capsules Containing Lactobacillus Casei
Patients in intervention group will receive one capsule containing 108cfu Lactobacillus Casei daily for two months.
Capsules should be taken with food and a glass of water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinologist Office Located in the Sheykholraees Clinic
Full name of responsible person
Dr. Ismail Faraji - Endocrinologist, Department of Faculty of Medicine