Protocol summary

Study aim
The aim of this study was to investigate the effect of twelve weeks of moderate-intensity aerobic exercise and Aphrodite supplement on level of some neural factors related to mental and psychological disorders of postmenopausal women
Design
200 married postmenopausal women are divided into four groups. The first group, the control group, the second group, the program of aerobic exercises, walking and light jogging with moderate intensity of 65-70% heart rate on the treadmill for twelve weeks, the third group, twelve weeks of aerobic exercise plus two doses per day of Aphrodite supplement, and the fourth group only two doses per day of the supplement. Aphrodite
Settings and conduct
Study place: Mostaghni gym club. We will give a questionnaire to 200 married postmenopausal women between 55 and 60 years of age with six-month LMP and serum estradiol less than 35 picogram per deciliter with healthy physical condition. Each of them is tested and sampled and then they are divided into four groups and they benefit from supplements and aerobic exercise for 12 weeks and at the end, the testing is done again.
Participants/Inclusion and exclusion criteria
Two hundred menopausal women residing in Isfahan Province, who had mild depression according to the Hamilton Depression Questionnaire, people should not have certain chronic and systemic diseases (especially cardiovascular problems) and should not take any other drugs during the study period.
Intervention groups
Participants were divided into six groups: control, aerobic exercise, aphrodisiac supplementation, and aerobic exercise+ aphrodisiac supplementation, based on the inclusion criteria.
Main outcome variables
Superoxide dismutase (SOD); malondialdehyde (MDA);

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231009059661N1
Registration date: 2023-12-30, 1402/10/09
Registration timing: retrospective

Last update: 2023-12-30, 1402/10/09
Update count: 0
Registration date
2023-12-30, 1402/10/09
Registrant information
Name
Farzaneh Mostaghni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3565 6598
Email address
f.mostaghni.is@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-01, 1402/08/10
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of aerobic exercise and Aphrodite supplement on the level of some oxidative stress factors and neurogenesis of transmitters related to mental and psychological disorders of postmenopausal women with depression
Public title
Effect of aerobic exercise and supplement on ROS and neurogenesis in depressed postmenopausal women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
6 months old LMP and serum estradiol less than 35 picogram per deciliter BMI between 26-29 Moderate depression using a questionnaire based on Beck anxiety inventory (BAI)
Exclusion criteria:
Not having any special chronic or systemic disorder
Age
From 55 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
N/A
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 Azad Islamic University of Isfahan(Khorasgan)
Street address
Azad Islamic University- Daneshgah Blvd- Arghavanieh Street
City
Khorasgan
Province
Isfehan
Postal code
8155139998
Approval date
2023-02-14, 1401/11/25
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.389

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes

Primary outcomes

1

Description
Malondialdehyde(MDA)
Timepoint
Before starting the intervention and twelve weeks after that
Method of measurement
serum concentration of CGRP by ELISA method

2

Description
Superoxide dismutase(SOD)
Timepoint
Before starting the intervention and twelve weeks after that
Method of measurement
serum concentration of superoxide dismutase by ELISA method

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: twelve weeks aerobic exercise, from 50 pre cent of HRm(in first week) to 70 pre cent of that in last five weeks
Category
Treatment - Drugs

2

Description
Intervention group 2: 12 weeks of aerobic training plus Aphrodite supplement twice a day (each capsule contains 40 mg of sea buckthorn fruit, 72.12 mg of ginger, 3.3 mg of saffron and 11 mg of cinnamon and weighs approximately 70 mg has it .
Category
Treatment - Drugs

3

Description
Intervention group 3: using Aphrodite supplement twice a day for twelve weeks (each capsule contains 40 mg of sea buckthorn fruit, 72.12 mg of ginger, 3.3 mg of saffron and 11 mg of cinnamon and weighs approximately 70 mg has it )
Category
Treatment - Drugs

4

Description
Control group: without intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostaghni gym
Full name of responsible person
Farzaneh Mostaghni
Street address
5th Alley, South Tohid street
City
Isfahan
Province
Isfehan
Postal code
8173963913
Phone
+98 31 3268 5785
Email
f.mostaghni.is@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Isfahan(Khorasgan) branch research Deputy
Full name of responsible person
Farzaneh Mostaghni
Street address
Islamic Azad University, Arghavanieh Ave, Khorasgan
City
Isfahan
Province
Isfehan
Postal code
8755181551
Phone
+98 31 3500 2000
Email
f_taghian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Isfahan(Khorasgan) branch research Deputy
Proportion provided by this source
50
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
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University Isfahan(Khorasgan) branch, Arghavanieh Ave
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
0098 31 335002352
Email
F_taghian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Mostaghni
Position
student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University- Arghavanieh st- Isfahan
City
Isfahan
Province
Isfehan
Postal code
8173963913
Phone
+98 31 3268 5785
Email
f.mostaghni.is@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan Unversity- Arghavanieh St- Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
F_taghian@yahoo.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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