History
# Registration date Revision Id
1 2015-12-29, 1394/10/08 3183
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Protocol summary

Summary
(1)Objectives: The effect of Symbiotic supplements on some biochemical characteristics in women with gestational diabetes mellitus. (2 )Design: Randomized Double blind clinical Trial. (3)Setting and conduct: The process of Balanced Block selection were performed until all the 90 patients were random divided into 2 groups. The first blood samples were taken from the subjects after assessing their anthropometric measurements and taking their 24 hour food recalls. Then, they were asked to consume either of the symbiotic or placebo capsules for 6 weeks. Subjects were asked not to consume any symbiotic-containing food, yogurt or its products during the intervention. More so, they were asked not to change their regular diet, activity and medicine during the study. Second Blood samples were also taken after an overnight fasting and before-after analysis was performed finally. (4)Participants including major eligibility criteria: (4-a) Major Inclusion Criteria: Women with gestational diabetes mellitus. (4-b) Major Exclusion Criteria: A history of diabetes before pregnancy; blood pressure; tobacco and alcohol use; Having Eclampsia and pre-eclampsia; clinical signs of some chronic or acute diseases. (5)Intervention: Group 1 (Intervention group) who daily received 1 capsule containing 500 mg probiotic supplements after the lunch meal, and Group 2 (Placebo group) who received placebo as the same, all for 6 weeks. (6)Main outcome measures (Variables): Fasting blood sugar, Serum insulin, Total Cholesterol, LDL-C, HDL-C, TG and HOMA-IR, Insulin sensitivity

General information

Acronym
Symbiotic and Gestational Diabetes Mellitus
IRCT registration information
IRCT registration number: IRCT201511183140N16
Registration date: 2015-12-29, 1394/10/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-12-29, 1394/10/08
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-11-09, 1394/08/18
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of symbiotic supplementation on lipid profile, glycemic control and hs-CRP in women with gestational diabetes mellitus
Public title
Effect of symbiotic supplementation on lipid profile, glycemic control and hs-CRP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion/exclusion criteria : Inclusion criteria: All pregnant women diagnosed with gestational diabetes (women who began treatment with insulin.); The age range was 18 to 40 ; 28-24 weeks of pregnancy ; Singleton pregnancies; Lack of pre-eclampsia and eclampsia. Exclusion criteria: Pregnant women with a history of diabetes before pregnancy; Gestational hypertension (blood pressure equal to or greater than 140/90, without proteinuria is created at mid-pregnancy.); Age <18 years and over 40 years; Women with a history Multiple pregnancy or fetal malformations; Women in pregnancy week> 28 ; People who show sensitivity to symbiotic or placebo capsules during the study; Those consume with less than 90% symbiotic or placebo capsules ; Tobacco and alcohol use; Pregnant women with a history of diseases affecting the metabolism of glucose, infection, chronic diseases, women consumers of antibiotics; Pregnant women with diseases such as immune deficiency, heart valve disease, syndrome Short bowel ischemia risk; If someone without pre-eclampsia and eclampsia recruited, but the poisoning was diagnosed during the study will be excluded
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
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
Vice Chancellor for Research and Technology
Street address
Third floor, Central building No. 2, Tabriz University of Medical Sciences, Golgasht- street
City
Tabriz
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
TBZMED.REC.1394.688

Health conditions studied

1

Description of health condition studied
gestational diabetes mellitus
ICD-10 code
O24.4
ICD-10 code description
Diabetes mellitus arising in pregnancy

Primary outcomes

1

Description
HOMA-IR
Timepoint
Baseline and after 6 weeks
Method of measurement
Formula

2

Description
Insulin Sensitivity
Timepoint
Baseline and after 6 weeks
Method of measurement
QUICKI Index

3

Description
Fasting Blood Sugar
Timepoint
Baseline and after 6 weeks
Method of measurement
Biochemical Analysis

4

Description
Serum Insulin
Timepoint
Baseline and after 6 weeks
Method of measurement
ELIZA

5

Description
Lipid profile: Total cholesterol, Triglyceride, HDL-C, LDL-C
Timepoint
Baseline and after 6 weeks
Method of measurement
Biochemical Analysis

6

Description
hs-CRP
Timepoint
Baseline and after 6 weeks
Method of measurement
ELIZA

Secondary outcomes

1

Description
Dietary Factors
Timepoint
Baseline and after 6 weeks
Method of measurement
3 day 24 hour food recall questionnaire

Intervention groups

1

Description
Intervention Group:Women with Gestational Diabetes Mellitus receive 1 Lactofem Symbiotic Capsule one a day (After lunch), for 6 weeks. Each capsule contains 500 mg Symbiotic which precisely consist of the following strains and species 1) Lactobacillus acidophilus 5×10 10 CFU/g 2) Lactobacillus plantarum 1.5×10 10 CFU/g 3) Lactobacillus fermentum 7×10 9 CFU/g 4) Lactobacillus Gasseri 2× 10 10 CFU/g
Category
Treatment - Drugs

2

Description
Placebo Group: Receiving 1 Placebo Capsules ones a day (after lunch), containing lactose, Colloidal silicon dioxide, Mg stearate, talc, Magnesium Stearate for 6 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Zohoor Nabhani
Street address
Tehran, Keshavarz Blvd, Imam Khomeini Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nutrition Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. AliReza Ostad Rahimi
Street address
Faculty of Nutrition, Attar street, Golgasht street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center, Tabriz 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
Tabriz University of Medical Sciences, Faculty of Nutrition, Tabriz
Full name of responsible person
Zohoor Nabhani
Position
MSc Student of Health Science in Nutrition
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3281 9128
Fax
Email
zohoor.nabhani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Nutrition
Full name of responsible person
Dr Bahram Pourghassem Gargari
Position
Ph.D. in Nutrition
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 2117
Fax
Email
bahrampg@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences, Faculty of Nutrition
Full name of responsible person
Zohoor Nabhani
Position
MSc Student of Health Science in Nutrition
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3281 9128
Fax
Email
zohoor.nabhani@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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