Comparison of effects of consumption of probiotic and conventional yogurt on oxidative stress and serum TNF-α and CRP in pregnant women and anthropometric indices of neonates
1- Objectives: Previous studies have shown that oxidative stress increases in pregnancy and is associated with several complications of pregnancy. Clinical trials in non-pregnant women have shown that probiotics can decrease oxidative stress. The aim of this study is to determine effects of probiotic yogurt compared to conventional yogurt on oxidative stress and inflammatory markers in pregnant women and anthropometric indices of their neonates.
2- Design: randomized controlled trial
3- Setting and conduct: A hundred healthy pregnant women will be referred from Naghavi Clinic, Kashan University of Medical Sciences. After a 2-week washout period, they will be randomly allocated to receive daily either 200 gram probiotic or conventional yogurt for 9 weeks. Ten milliliters of venous fasting blood sample will be collected at baseline and after intervention. Women will be followed up till delivery. Anthropometric indices of neonates will be measured within the first 24 hours after birth.
4- Participants: healthy pregnant women aged 18-30 years at gestational week 26, Exclusion criteria: premature labor; gestational diabetes or other complications of pregnancy; having illness including cardiovascular , liver or kidney disease
5- Intervention: 200 gram probiotic or conventional yogurt daily for 9 weeks
6- Main outcome measures variables: serum C-reactive protein, glutathione reductase, glutathione peroxidase, 8-oxy-guanine and tumor necrosis factor-alpha, plasma total antioxidant capacity and weight, height and head circumference of neonates
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811282394N3
Registration date:2011-06-06, 1390/03/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-06, 1390/03/16
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2011-07-01, 1390/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effects of consumption of probiotic and conventional yogurt on oxidative stress and serum TNF-α and CRP in pregnant women and anthropometric indices of neonates
Public title
Effects of consumption of probiotic yogurt in pregnancy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria
1- Pregnant women aged 18-30 years;
2- Willing to participate;
3- First pregnancy;
Exclusion criteria:
1- Premature labor;
2- Gestational diabetes or other complications of pregnancy;
3- Having illness including cardiovascular , liver or kidney disease
Age
From 18 years old to 30 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2010-10-10, 1389/07/18
Ethics committee reference number
20402
Health conditions studied
1
Description of health condition studied
Pregnancy
ICD-10 code
094
ICD-10 code description
Sequelae of complication of pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
total antioxidant capacity
Timepoint
at baseline, after 9 weeks
Method of measurement
colorimetric
2
Description
glutathione peroxidase
Timepoint
at baseline, after 9 weeks
Method of measurement
spectrophotometery
3
Description
glutathione reductase
Timepoint
at baseline, after 9 weeks
Method of measurement
spectrophotometery
4
Description
8-oxy-guanine
Timepoint
at baseline, after 9 weeks
Method of measurement
ELISA
5
Description
tumor necrosis factor-alpha
Timepoint
at baseline, after 9 weeks
Method of measurement
ELISA
6
Description
C-reactive protein
Timepoint
at baseline, after 9 weeks
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
200 gram probiotic yogurt daily
at lunch time
for 9 weeks
Category
Other
2
Description
200 gram conventional yogurt daily
at lunch time
for 9 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Naghavi Clinic, Kashan University of Medical Sciences
Full name of responsible person
Dr. Samimi
Street address
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Ali Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd, Tehran, Iran.
City
Tehran
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, Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Nutrition, School of public Health, Tehran University of Medical Sciences
Full name of responsible person
Shima Jazayeri
Position
MD, PhD /Assistant Professor
Other areas of specialty/work
Street address
Department of Nutrition, School of public Health, Tehran University of Medical Sciences, #52, Alvand Street, Argantin Square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
sh_jazayeri@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)