Effects of probiotic yogurt consumption on some inflammatory biomarkers ( hs-CRP,IL-6,TNF-α),glacated hemoglobine,lipid profile and gi symptoms in patients with type 2 diabetes
The purpose of this study is to compare the effect of probiotic and conventional yogurt on some biochemical parameters in patients with type 2 diabetes.
Forty- four patients with type 2 diabetes from both of sex and aged between 35-55 years old are assigned to two intervention and control groups. The subjects in the intervention group consum 300 g/d probiotic yogurt(contained Bifidobacterium animalis subsp. lactis (Bb12) and Lactobacillus acidophilus La5) and subjects in the control group consum 300g/d conventional yogurt for 8 weeks. Anthropometric indices, dietary intakes, serum levels of glucose, IL-6, TNF-α , hs-CRP, HbA1c, lipid profile and gi symptoms are evaluated at the beginning and end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014021516588N1
Registration date:2014-03-04, 1392/12/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-04, 1392/12/13
Registrant information
Name
Fatemeh Mohammadi
Name of organization / entity
School of Paramedicine, Ahvaz Jondishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1635 2890
Email address
mohamadyf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jondishapur University Of Medical Sciences
Expected recruitment start date
2012-01-05, 1390/10/15
Expected recruitment end date
2012-07-05, 1391/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic yogurt consumption on some inflammatory biomarkers ( hs-CRP,IL-6,TNF-α),glacated hemoglobine,lipid profile and gi symptoms in patients with type 2 diabetes
Public title
The effects of probiotic yoghurt on type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having type 2 diabetes, 35 to 55 years old, BMI ≤30, LDL level more than 100 mg/dl.
Exclusion criteria: cardiovascular disease,renal dysfunction,chronic inflammatory diseases; inflammatory bowel disease, thyroid disorders and lactose intolerance, treatment with insulin and taking corticosteroids, NSAIDS, immunosuppressives, cholesterol lowering drugs, multivitamin-mineral , fiber and omega 3 supplements, smoking, pregnancy and lactation, having any weight loose or weight gain regimes, use of antibiotics
Age
From 35 years old to 55 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
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Approval date
2012-01-07, 1390/10/17
Ethics committee reference number
ETH.363
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Hemoglobin A1c
Timepoint
Before and after 8 weeks
Method of measurement
Chromatography
2
Description
Fasting Blood Sugar
Timepoint
Befor and after 8 weeks
Method of measurement
spectrophotometry
3
Description
Total Cholesterol
Timepoint
Before and after 8 weeks
Method of measurement
Spectrophotometry
4
Description
Triglyceride
Timepoint
Before and after 8 weeks
Method of measurement
Spectrophotometry
5
Description
HDL-c
Timepoint
Before and after 8 weeks
Method of measurement
Spectrophotometry
6
Description
LDL-c
Timepoint
Before and after 8 weeks
Method of measurement
Friedewald Formula
7
Description
hs-CRP
Timepoint
Before and after 8 weeks
Method of measurement
ELISA
8
Description
TNF-α
Timepoint
Before and after 8 weeks
Method of measurement
ELISA
9
Description
Interlukine-6
Timepoint
Before and after 8 weeks
Method of measurement
ELISA
10
Description
Gi symptoms
Timepoint
Before and after 8 weeks
Method of measurement
Gi symptoms questionarie
Secondary outcomes
1
Description
Dietary Factors
Timepoint
Before and after 8 weeks
Method of measurement
3-day 24h dietary recalls
2
Description
Hip circumference
Timepoint
Before and after 8 weeks
Method of measurement
Meter
3
Description
Body weight
Timepoint
Before and after 8 weeks
Method of measurement
Digital scale
4
Description
Waist circumference
Timepoint
Before and after 8 weeks
Method of measurement
Meter
Intervention groups
1
Description
The subjects in the intervention group consume 300 g/d probiotic yogurt containing 106 colony of both Lactobacillus acidophilus and Bifidobacterium lactis bacteria
Category
Treatment - Drugs
2
Description
Subjects in the control group consume 300g/d conventional yogurt.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital Endocrine Clinic
Full name of responsible person
Fatemeh Mohammadi
Street address
Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jondishapur University Of Medical Sciences
Full name of responsible person
Dr Majid Karandish
Street address
Ahvaz Jondishapur University Of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jondishapur University Of Medical Sciences
Proportion provided by this source
100
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
Name of organization / entity
School of Paramedicine, Ahvaz Jondishapur University Of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi
Position
Msc. in Nutrition sciences
Other areas of specialty/work
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
f.mohamadi2008@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Paramedicine, Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Dr Majid Mohamadshahi
Position
PhD. in Nutrition sciences
Other areas of specialty/work
Street address
Ahvaz Jodishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1373 8253
Fax
Email
shahi334@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Paramedicine, Ahvaz Jondishapur University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi
Position
Msc. in Nutrition Sciences
Other areas of specialty/work
Street address
Ahvaz Jondishapur University of Medical Sciences, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)