Protocol summary

Summary
1- Objectives: Assessing the effect of probiotics on mental health, stress oxidative and inflammatory indices in Petrochemical staff; 2- Design: Double-blinded Randomized Clinical Trial; 3- Setting, conducting and intervention: To conduct this study, the staff of Petrochemical Research & Technology Co., aging between 20 - 60, was invited. After signing the Consent Form by the eligible persons, 35 labors were randomly divided into three groups, to receive “100 grams of probiotics yogurt + placebo” or “ordinary yogurt+ probiotics supplement” or “ordinary yogurt + placebo” for 6 weeks. All three groups were advised not to change their normal diet or activities. Fasting blood tests were performed on all three groups before and after intervention. The 24-Hour Dietary Recall Questionnaire (to investigate the energy and nutritional intake), the International Physical Activity Questionnaire (IPAQ), and anthropometric data including weight, height, BMI and blood pressure have been completed at the beginning of the study and also at the end of the sixth week; 4- Main inclusion criteria: Having good physical health conditions and not taking any nutritional supplements in the last two months, and not taking any medicine (anti-depression, NSAID, etc.); Main exclusion criteria: Not following the treatment (using less than 80% of yogurts or supplements); 5- Main outcome measures: It seems that Probiotics causes the decrease in inflammatory factors and stress oxidative, and also have a positive effect on mental health.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201406222394N11
Registration date: 2014-12-02, 1393/09/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-02, 1393/09/11
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
All costs of this study is born by “National Petrochemical Company of Iran”
Expected recruitment start date
2014-02-05, 1392/11/16
Expected recruitment end date
2014-03-19, 1392/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Probiotics on Mental Health,Serum Neuropeptide Y, CRP and INF-γ, Kynurenine Pathway,Hypothalamus-Pituitary-Adrenal Axis Activity and Oxidative StressinWorkers of Petrochemical Company
Public title
The Effect of Probiotics on Mental Health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: 1. Having the willingness to participate in the study and signing an informed consent form; 2. Having at least one-year work experience in Petrochemical Research & Technology Co.; 3. Aging between 20 and 60; 4. Having good physical health conditions based on the clinical history; 5. Not using nutritional supplements in the last 2 months; 6. Not taking medicines (anti-depression, NSAID, etc.); 7. GHQ score of equal or more than 9. Exclusion Criteria: 1. Smoking cigarettes in the last year; 2. Having an unwillingness to participate; 3. Not following the treatment (using less than 80% of yogurts or supplements); 4. Having physical sickness or taking any kind of medicine or supplements during the intervention.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 35
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 Tehran University of Medical Sciences
Street address
Floor 6, the Central Building of University, corner of Ghods St., Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2013-05-21, 1392/02/31
Ethics committee reference number
130/324/د/92

Health conditions studied

1

Description of health condition studied
Healthy persons exposed to petrochemical pollutants.
ICD-10 code
Z57.5
ICD-10 code description
Occupational exposure to toxic agents in other industries

Primary outcomes

1

Description
Fat intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

2

Description
mental health
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
GHQ (General Health Questionnaire)

3

Description
Neuropeptide Y (NPY)
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

4

Description
CORTISOL
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

5

Description
( Adrenocorticotropic hormone)ACTH
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

6

Description
carboniylated Protein
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

7

Description
Kynurenine (KYN)
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

8

Description
Isoprostane F2α
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

9

Description
hydroxydeoxyguanosine (8-OHdG)
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

10

Description
Oxidized low-density lipoprotein (Ox-LDL)
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

11

Description
Interferon gamma (IFNγ)
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

12

Description
Tryptophan
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Blood Test

13

Description
Physical Activity
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
International Physical Activity Questionnaire(IPAQ)

14

Description
Age
Timepoint
Beginning of the study
Method of measurement
Question

15

Description
Height
Timepoint
Beginning of the study
Method of measurement
Height measurement with Seca Stadiometer

16

Description
Body mass index (BMI)
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Weight in Kilograms divided by height in meters squared(weight(kg)/[height(m)2])

17

Description
Energy intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

18

Description
Weight
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
Weight measurement with at least clothes by Seca Digital Scale with readability of 100g.

19

Description
Protein intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

20

Description
Carbohydrate intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

21

Description
Saturated fat intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

22

Description
Mono-unsaturated fat intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

23

Description
Poly unsaturated fat intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

24

Description
Cholesterol intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

25

Description
Fiber intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

26

Description
Vitamin A intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

27

Description
Vitamin C intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

28

Description
Vitamin E intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

29

Description
Copper intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

30

Description
Selenium intake
Timepoint
At the begininng of the study and the end of 6th week.
Method of measurement
The 24-Hour Dietary Recall Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
One capsule of placebo and 100 grams of ordinary yogurt.
Category
Placebo

2

Description
Probiotics capsule twice a day and 100 grams of ordinary yogurt
Category
Treatment - Drugs

3

Description
100 grams of probiotics yogurt and placebo
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Petrochemical Research & Technology Co.
Full name of responsible person
Mehdi Yosefi
Street address
Polymer & Petrochemical Research Institute, P.O. Box 14965/115, Research Blv., 15th km of Karaj Highway, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Petrochemical Research & Technology Co.+ Vice Chancellor of Research, Iran University of Medical Sc
Full name of responsible person
Esmail Ghanbari+ Dr. Seyed AliJavad Mousavi
Street address
No. 27, Sarve Alley, Southern Shirazi, Mollasadra, P.O. Box 14358,Tehran , Iran.+ Iran University of Medical Sciences, Hematt express way, 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
Petrochemical Research & Technology Co.+ Vice Chancellor of Research, Iran University of Medical Sc
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
Iran University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
PhD student of Nutritional Sciences
Other areas of specialty/work
Street address
Hemmat Hwy,nexto Milad Tower, Iran University of Medical Sciences,Faculty of Health, Nutrition Department
City
Tehran
Postal code
Phone
+98 21 8895 2480
Fax
+98 21 8898 9081
Email
alisotood@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Depatment of Nutrition, Faculty of public Health, Iran university of medical sciences
Full name of responsible person
Shima Jazayeri
Position
PhD.assistant prof.
Other areas of specialty/work
Street address
Faculty of public health, Iran university of medical sciences, next to Milad tower, Hemmat Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 8670 4805
Fax
Email
sh_jazayeri@.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
PhD student of Nutritional Sciences
Other areas of specialty/work
Street address
Hemmat Hwy,nexto Milad Tower, Iran University of Medical Sciences,Faculty of Health, Nutrition Department
City
Tehran
Postal code
Phone
+98 21 8895 2483
Fax
+98 21 8898 9081
Email
alisotood@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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