The effects of consumption of probiotic yoghurt and conventional yoghurt on blood sugar, lipid profile, oxidative stress parameters and inflammatory marker in type 2 diabetic patients.
The aim of this randomized double blind clinical trial is to determine the effects of probiotic yoghurt consumption on some blood biochemical parameters in type 2 diabetic patients. Sixty patients aged between 30-60 years old from both sexes are assigned into two groups. Patients in intervention group consume 300 gr/day probiotic yoghurt and patients in control group consume 300 gr/day conventional yoghurt for 6 weeks. Anthropometric and blood pressure measurements, 3-day 24h dietary recalls and fasting blood samples are collected at the beginning and at the end of study. Fasting blood sugar, glycosylated hemoglobin, insulin, lipid profile, malondialdehyde (MDA), total antioxidant capacity (TAC), catalase, superoxide dismutase, glutathione peroxidase and hsCRP are measured. LDL and HOMA-IR are calculated by formula. The participants are asked not to change their regular diet, medicine and activity during the study and not to consume any other yoghurt.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903223533N1
Registration date:2010-07-03, 1389/04/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-07-03, 1389/04/12
Registrant information
Name
Javad Mohtadinia
Name of organization / entity
Faculty of health and nutrition
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7581
Email address
mohtadiniaj@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences, Iran Dairy Industries Company
Expected recruitment start date
2010-05-31, 1389/03/10
Expected recruitment end date
2010-07-12, 1389/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of consumption of probiotic yoghurt and conventional yoghurt on blood sugar, lipid profile, oxidative stress parameters and inflammatory marker in type 2 diabetic patients.
Public title
The effects of probiotic yoghurt on type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having type 2 diabetes, 30 to 60 years old, LDL level more than 100 mg/Dl
Exclusion criteria: having the renal or hepatic failure, cardiovascular disease, inflammatory bowel disease, thyroid disorders and lactose intolerance, treatment with insulin and taking corticosteroids, NSAIDS, immunosuppressives, cholesterol lowering drugs, multivitamin-mineral and fiber supplements, BMI more than 35 Kg/m2, smoking, pregnancy and lactation, use of multivitamin-mineral and fiber supplements 3 weeks prior to the study, use of antibiotics 1 month the study and during the study, having acute gastrointestinal disorders 1 month prior to the study and during the study
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Tabriz University of Medical Sciences