Protocol summary

Study aim
Investigating the effect of exercise snacks on insulin resistance and hormones involved in the menstrual cycle of overweight women
Design
24 volunteers are randomly divided into two training groups or control groups, using computer generated sequences.
Settings and conduct
The study involved women aged 20–30 with a BMI of 25–30 (overweight), regular menstrual cycles, no exercise history, and no contraceptive use. Participants were randomly assigned to exercise or control groups. Two fasting blood samples (4 cc) were collected: the first during days 3–5 of the menstrual cycle and the second 48 hours after the final exercise session within the same cycle. The 8-week exercise protocol was explained to the exercise group, while the control group was asked to avoid physical activity. Participants provided written consent before the study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Full health؛ Not using oral contraceptive pills؛ Regular menstrual cycle؛ Overweight women؛ No prior history of physical activity Exclusion Criteria: Irregular menstrual cycle؛ Use of oral contraceptive pills؛ Suffering from specific medical conditions
Intervention groups
The 8-week training protocol involves three daily sessions with 1 to 4 hours between them. Each session starts with a warm-up (10 jumping jacks, 10 squats, and 5 lunges). In the first 4 weeks, the exercises are jumping jacks, step-ups, and wall squats, each for 30 seconds with maximum effort, followed by a 1-minute rest. In the second 4 weeks, rope jumping is added, and the rest period between exercises is reduced to 30 seconds.
Main outcome variables
Luteinizing hormone؛ follicle stimulating hormone؛ fasting glucose؛ fasting insulin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241128063885N1
Registration date: 2025-04-23, 1404/02/03
Registration timing: retrospective

Last update: 2025-04-23, 1404/02/03
Update count: 0
Registration date
2025-04-23, 1404/02/03
Registrant information
Name
Maryam Boustani
Name of organization / entity
Allame Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 21 4839 0000
Email address
boustani_maryam@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
2024-02-19, 1402/11/30
Actual recruitment end date
2024-05-19, 1403/02/30
Trial completion date
empty
Scientific title
The effect of mid-day snack exercise on insulin resistance and level of LH and FSH hormones in overweight women
Public title
The effect of mid-day snack exercise on health of overweight women
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
No history of physical exercise Full health No use of contraceptive drugs No use of contraceptive drugs
Exclusion criteria:
Age
From 20 years old to 30 years old
Gender
Female
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
This study will use a simple randomization method. Participants will be randomly assigned to two groups: an intervention group that will engage in practice and a control group. Randomization will be conducted at the individual level, with each of the 24 participants in the study being allocated to one of the two groups. A computerized sequence will be used to randomly assign participants to each group. This approach ensures high precision and reproducibility while minimizing selection bias.
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
Research Ethics Committees of Allameh Tabatabai University (ATU)
Street address
13th Floor, Block A, Ministry of Health, Treatment, and Medical Education, Tehran, Qods Town, between Zarafshan and Felmek South.
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.ATU.REC.1402.032

Health conditions studied

1

Description of health condition studied
Overweight women
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Luteinizing hormone
Timepoint
Before starting the intervention and then doing the 8-week protocol
Method of measurement
Biochemical and laboratory methods

2

Description
Follicle stimulating hormone
Timepoint
Before starting the intervention and then doing the 8-week protocol
Method of measurement
Biochemical and laboratory methods

3

Description
Fasting glucose
Timepoint
Before starting the intervention and then doing the 8-week protocol
Method of measurement
Biochemical and laboratory methods

4

Description
Fasting insulin
Timepoint
Before starting the intervention and then doing the 8-week protocol
Method of measurement
Biochemical and laboratory methods

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: exercise snack group, this group will do 8 weeks of activity according to the protocol.
Category
Lifestyle

2

Description
Control group: without exercising، asked to them that avoid any sports activities for 8 weeks.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Tabatabai University
Full name of responsible person
Maryam Boustani
Street address
Olympic Village, Sports Square, Allameh Tabatabai University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
ict@atu.ac

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabataba'i University
Full name of responsible person
Ehsan Zareian
Street address
Olympic Village, Sports Square, Allameh Tabatabai University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
ict@atu.ac
Grant name
This study was conducted without receiving any funding at Allameh Tabataba'i University and with the non-financial support of the university's Research Deputy.
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabataba'i University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Allameh Tabatabai University
Full name of responsible person
Maryam Boustani
Position
Student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
The address in English would be: Olympic Village, Sports Square, Allameh Tabatabai University, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Email
Boustani_maryam@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allame Tabataba'i University
Full name of responsible person
Maryam Boustani
Position
Sports physiologist
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Sports Square, Sports Street, Olympic Village Street, Olympic Village, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Fax
Email
boustani_maryam@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Allame Tabataba'i University
Full name of responsible person
Maryam Boustani
Position
Sports physiologist
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Sports Square, Sports Street, Olympic Village Street, Olympic Village, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1489684511
Phone
+98 21 4839 0000
Fax
Email
boustani_maryam@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The report will be sent to the research vice-chancellor of the university. It is also published as an article
When the data will become available and for how long
2025
To whom data/document is available
All researchers
Under which criteria data/document could be used
Citing references
From where data/document is obtainable
Scientific bases and Allameh Tabatabai University of Iran
What processes are involved for a request to access data/document
Maximum one week
Comments
Loading...