History
# Registration date Revision Id
3 2022-11-12, 1401/08/21 245555
2 2022-02-23, 1400/12/04 218059
1 2021-08-22, 1400/05/31 194869
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
Evaluate the effect of intense interval resistance training and vitamin D intake on the levels of sirtoin 1, eutoxin-1 and some anti-inflammatory-oxidative markers in overweight women with low vitamin D status.
Design
This study is a quasi-experimental one-blind clinical trial that will be performed using a pre- post test design with a control group in a single blind manner. Subjects were randomly divided into four groups: control, exercise, vitamin D and combined. The exercise and combined groups perform 8 weeks of high intensity interval resistance training. Vitamin D and exercise+vitamin D groups will receive 50,000 IU of Vitamin D per week for 8 weeks.
Settings and conduct
The statistical population includes sedentry young women with body mass index between 25 and 29 kg/m2), aged 45-55 years, referred to Babol sports clubs. high intensity interval resistance training are performed at 70% of 1RM and three sessions per week for 8 weeks at the Paya Sports Club in Babol. Subjects in the vitamin D and combination groups vitamin D, and exercise and control groups will receive placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being overweight, being a non-athlete, having levels of 25-hydroxyvitamin D less than 30 ng/ml .Exclusion critiaer:Smoking, use of special drugs, use of any supplements.
Intervention groups
The training group performs high intensity interval resistance training for 8 weeks, iwith an intensity of 70% of a maximum repetition. The supplement group will take 50,000 units of vitaminD capsules weekly for 8 weeks .The supplement+exercise group is similar to the other two groups doing a week of exercise with vitamin D intake. The control group does not undergo intervention.
Main outcome variables
25 Hydroxy vitamin D,Siirtoin 1, eutoxin-1,Inflammatory and anti-inflammatory markers, antioxidant markers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190831044650N3
Registration date: 2021-08-22, 1400/05/31
Registration timing: registered_while_recruiting

Last update: 2021-08-22, 1400/05/31
Update count: 2
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Masoumeh Habibian
Name of organization / entity
Qaemshahar Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 11 4224 1041
Email address
habibian.masoumeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-21, 1400/05/30
Expected recruitment end date
2021-09-21, 1400/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high intensity interval resistance training and vitamin D intake on the levels of Sirtuin1, Eotaxin-1 and some anti inflammatory-oxidative markers in overweight women with low vitamin D status.
Public title
The effect of high intensity interval resistance training and vitamin D intake onvitamin D th and anti inflammatory-oxidative status in overweight women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a body mass index between 25 to 29 kg / m2 Not participating in regular sports activities for the past six months Not having cardiovascular disease Not having hypertension Not having Inflammatory diseases Serum levels of 25-hydroxyvitamin D less than 30 ng / ml
Exclusion criteria:
Use any specific medications or supplements Pregnancy smoking
Age
From 23 years old to 29 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the subjects will be selected using a simple random method. Then, using a table of random numbers, they are divided into four groups: control, exercise, vitamin D and exercise + vitamin D. Therefore, each of the candidates will be assigned a two-digit number from 01, 02, …, 10, 11, …, to 52. The same number of digits is determined for the selection of individuals by starting a hand movement from a point in the table of random numbers in the direction of the desired row or column (five-digit numbers whose last two digits are similar to the existing codes) and each is randomly assigned to One of the groups. This will continue until the number of people in each group is completed. Therefore, the researcher will not have the option to change the status of the assignment or predict it. Random disguise will be done by a third party who does not participate in other stages of the intervention.
Blinding (investigator's opinion)
Single blinded
Blinding description
analysts will be blind. The researcher will administer vitamin D capsules (50,000 units) to vitamin D and exercise + vitamin D individuals as well as placebo to control and exercise groups
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sari branch, Islamic Azad University
Street address
7 km Darya Road, Sari, Islamic Azad University, Sari Branch, Iran
City
Sari
Province
Mazandaran
Postal code
48181-19318
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.IAU.SARI.REC.1400.004

Health conditions studied

1

Description of health condition studied
overweight
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

2

Description of health condition studied
Vitamin D deficiency
ICD-10 code
E50.5
ICD-10 code description
Vitamin D deficiency

Primary outcomes

1

Description
Eotaxin-1
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Using the ELISA method

2

Description
Sirtuin1
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Using the ELISA method

3

Description
interlukin10
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Using the ELISA method

4

Description
25- hydroxy vitamin D
Timepoint
Before and after interventions
Method of measurement
Using the ELISA method

5

Description
Brain-Derived Neurotrophic Factor
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Using the ELISA method

6

Description
Superoxide dismutase
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Laboratory methods

7

Description
Tumor necrosis factor alpha
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Using the ELISA method

8

Description
Monocyte Chemoattractant Protein 1
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Using the ELISA method

9

Description
Malondialdehyde
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
spectrophotometrically

Secondary outcomes

1

Description
sleep quality
Timepoint
Before and after interventions
Method of measurement
Sleep quality questionnaire

2

Description
Quality of Life
Timepoint
Before the intervention and 2 weeks after the intervention
Method of measurement
Quality of Life Questionnaire

Intervention groups

1

Description
Control group: There is no intervention in the control group and they are given placebo in a single blind manner
Category
Placebo

2

Description
Intervention group 1: Exercise group will perform 8 weeks and three times a week of high intensity interval resistance training consisting of three sets of 6 repetitions at 70% of 1repetition maximum (RM) and then 20 seconds of rest between repetitions until exhaustion repeated for 3 times with 2030” rest between sets. They will also take a placebo capsule containing oral paraffin weekly .
Category
Treatment - Other

3

Description
Intervention group II: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks.
Category
Treatment - Other

4

Description
Intervention group 3: Subjects in this group will have 8 weeks of high intensity interval resistance training similar to the exercise group and will consume 50,000 IU of vitamin D capsules once a week.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Paya Sports Siavash
Full name of responsible person
Ruhollah Akbari
Street address
Amirkola Belt, goalhaye12 street , Siavash Sports Club, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4715756135
Phone
+98 11 3239 3269
Email
akbarirohulah74@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sari branch, Islamic Azad University
Full name of responsible person
Dr. Sadegh Salmanpour
Street address
km 7 of Darya Road, Islamic Azad University, Sari Branch, Sari, Iran.
City
Sari
Province
Mazandaran
Postal code
48161-19318
Phone
+98 11 2213 2891
Fax
Email
info@iausari.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari branch, Islamic Azad 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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Qaemshahr branch, Islamic Azad University
Full name of responsible person
Masoumeh habibian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
7km Allameh Tabarasi street, Qaemshahr Branch, Islamic Azad University, Qaemshahr
City
Qaemshahr
Province
Mazandaran
Postal code
4765161964
Phone
+98 11 4224 1041
Email
habibian_m@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qaemshahr branch, Islamic Azad University
Full name of responsible person
Masoumeh Habibian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
7 kilometers from Allameh Tabari Street, Islamic Azad University of Ghaemshahr Branch, Ghaemshahr, Iran.
City
Ghaemshahr
Province
Mazandaran
Postal code
4765161964
Phone
+98 11 4224 1041
Email
habibian_m@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qaemshahr branch, Islamic Azad University
Full name of responsible person
Masoumeh habibian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
7km Allameh Tabarasi street, Qaemshahr Branch, Islamic Azad University, Qaemshahr
City
Qaemshahr
Province
Mazandaran
Postal code
4765161964
Phone
+98 11 4224 1041
Email
habibian_m@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
No - There is not a plan to make this available
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