Protocol summary

Study aim
In the current research, lactobacillus plantarum paraprobiotic cells have been used in Shahani grape drink to reduce stress in graduate students. ​
Design
In order to investigate the effect of a drink containing parapsychobiotics and removing the effect of grape juice on stress, a comparative method was used. This study was a double-blind clinical trial with a design of two groups before and after. The sample size was calculated based on Almada et al.'s study (10). They were tested to evaluate the effect of two types of drinks. In order to investigate and compare the effect of drinks, the amount of changes in stress-related indicators in the states of each of the consumers and their saliva before and after using the drink were measured qualitatively and quantitatively.
Settings and conduct
In order to investigate the effect of a drink containing parapsychobiotics and removing the effect of grape juice on stress, a comparative method was used. Each consumer was asked to consume 250 ml of the drink daily for 10 weeks. The place of one of the universities of Tehran province.
Participants/Inclusion and exclusion criteria
The criteria for entering the test include the company's consent, age between 20 and 30 years, not consuming alcohol, not suffering from various neurological, cardiac, blood pressure, and diabetes disorders, and not taking drugs that affect stress and the nervous system, and systolic blood pressure within the normal range.
Intervention groups
Based on the monitoring, 32 students were selected. These 32 people were divided into 2 groups. In fact, in this research, the main variable is the type of drink and the secondary variable (adjusting) is the gender of the consumers.
Main outcome variables
Salivary cortisol level, sleep quality level, general health, delay in falling sleep

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240128060833N1
Registration date: 2024-04-17, 1403/01/29
Registration timing: retrospective

Last update: 2024-04-17, 1403/01/29
Update count: 0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
Mohammad mahdi Gholian
Name of organization / entity
Malayer university
Country
Iran (Islamic Republic of)
Phone
+98 21 7731 4126
Email address
fzendeboodi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-29, 1402/02/09
Actual recruitment start date
2023-04-30, 1402/02/10
Actual recruitment end date
2023-07-09, 1402/04/18
Trial completion date
2023-07-16, 1402/04/25
Scientific title
Investigating the possibility of producing a beneficial non-alcoholic grape drink containing parapsychobiotics with the ability of reducing stress
Public title
Investigating the effect of paraprobiotics in stress treatment
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
student 20-30 yearss old
Exclusion criteria:
use of psychoactive drugs food allergy mental problems under treatment using probiotics using probiotic products
Age
From 24 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants: Although the participants were fully aware of the study and filled the consent form, they were not aware of the type of drink consumed. Clinical Caregiver: The person who was in contact with the control and treatment users answered their questions without knowing the drink consumed by each person. Evaluator: The evaluator collected the forms filled by the volunteers without knowing the drink consumed by each person. Data analysis: The person analyzing the data analyzed the data without knowing which person the collected data belongs to.
Placebo
Not used
Assignment
Single
Other design features
During the trial, the evaluators were asked to observe dietary restrictions by avoiding the consumption of other fermented products, probiotics or prebiotics. If these events happened, they would be recorded in the calendar.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics committee
Street address
malayer arak free way
City
ma
Province
Hamadan
Postal code
84621-65741
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.malayeru.REC.1400.012

Health conditions studied

1

Description of health condition studied
​Stress during the final exam
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
salivary cortisol
Timepoint
At the beginning of the study, after 5 and10 weeks after the start of drinking
Method of measurement
cortisol kit

Secondary outcomes

1

Description
Sleep quality, general health, sleep latency
Timepoint
At the beginning of the study and 5 and 10 weeks after the start of drinking
Method of measurement
28-question general health questionnaires, self-report depression and sleep quality, Pittsburgh sleep quality index, which measures sleep quality and insomnia

Intervention groups

1

Description
Intervention group: Drink containing the parapsychobiotic Lactobacillus plantarum with a concentration of 2 x 109 cells/mL, each person consuming it was asked to consume 250 ml of the drink daily for 10 weeks.
Category
Prevention

2

Description
Control group: a drink prepared from Shahani grape concentrate was used. Grape concentrate was mixed with water at a ratio of 7:1, and each subject was asked to consume 250 ml of the drink daily for 10 weeks.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran university
Full name of responsible person
arash babaei
Street address
Babaei free way
City
tehran
Province
Tehran
Postal code
7517836954
Phone
+98 916 364 6431
Email
a.babaei@malayeru.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Malayer university
Full name of responsible person
Arash Babaie
Street address
2, yes 11th, Emam Khomeini town, Babai freeway
City
tehran
Province
Tehran
Postal code
1659886643
Phone
+98 21 7731 4126
Email
fzendeboodi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Malayer university
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Malayer University
Full name of responsible person
Fatemeh Zendeboodi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Food Technology and Quality Control
Street address
46, Sorraya, shariati street
City
Tehran
Province
Tehran
Postal code
7517836954
Phone
+98 917 170 4557
Email
m.mahdi.gholian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Malayer University
Full name of responsible person
Fatemeh Zendeboodi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Food Technology and Quality Control
Street address
46, Sorraya, shariati street
City
Tehran
Province
Tehran
Postal code
7517836954
Phone
+98 917 170 4557
Email
m.mahdi.gholian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Malayer university
Full name of responsible person
Mohammad mahdi Gholian
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Food Technology and Quality Control
Street address
Babaei
City
Tehan
Province
Tehran
Postal code
1659886643
Phone
+98 21 7731 4126
Fax
Email
fzendeboodi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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