IRCT | 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.

#	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

Protocol summary

Study aim: Evaluate the effect of intense interval resistance and running training with vitaminD intake on the levels of sirtoin1, eutoxin-1 and some anti-inflammatory-oxidative markers in overweight women with low vitaminD 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 for 8 weeks. Subjects were randomly divided into six groups: control, vitaminD, resistance interval, running interval, resistance interval+vitaminD and running interval+vitaminD. Exercise or combinations with vitaminD groups perform the prescribed exercises. VitaminD and exercise+vitaminD groups will receive 50,000IU of VitaminD weekly.
Settings and conduct: The statistical population includes sedentry women with body mass index between 25-29kg/m2, referred to Babol sports clubs. High intensity interval resistance and/or running training are performed three sessions per week for 8 weeks at the Paya Sports Club in Babol. Subjects in the vitaminD or combination groups, and the exercises or control groups, will take supplement and placebo, respectively.
Participants/Inclusion and exclusion criteria: Inclusion criteria: Being overweight, being a non-athlete, having levels of 25-hydroxyvitaminD less than 30ng/ml .Exclusion critiaer: Smoking, use of special drugs, use of any supplements.
Intervention groups: The training groups performs high intensity interval resistance (with an intensity of 70% of 1RM) and/or running (12x1-min running bouts at 80-90% HRmax) trainig for 8 weeks.The supplement group will take 50,000IU of vitaminD capsules weekly for 8 weeks .Supplemental+training groups, in addition to performing the desired exercises, similar to the supplement group, take vitaminD. The control group does not undergo intervention.
Main outcome variables: Siirtoin1, eutoxin-1,Inflammatory and anti-inflammatory markers, antioxidant markers

General information

Reason for update: Add study on the effect of high-intensity interval running exercises, in addition to studying the effect of high-intensity resistance training exercises and comparing the effect of these two types of exercises on the studied variables(Due to the commonality of control and Supplement groups)
Acronym
IRCT registration information: IRCT registration number: IRCT20190831044650N3

Registration date: 2021-08-22, 1400/05/31

Registration timing: registered_while_recruiting

Last update: 2022-11-12, 1401/08/21

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: 78

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 six groups: control, resistance interval, running interval, vitamin D, resistance interval+vitamin D and running interval+ 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, resistance interval+ vitamin D, running interval+ 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

10

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

11

Description: Total Antioxidant Capacity
Timepoint: Before the intervention and 8 weeks after the intervention
Method of measurement: Ferric Reducing/Antioxidant Power

12

Description: Transforming growth factor-beta 1 (TGF-beta1)
Timepoint: Before the intervention and 8 weeks after the intervention
Method of measurement: Using the ELISA method

13

Description: Vascular endothelial growth factor (VEGF)
Timepoint: Before the intervention and 8 weeks after the intervention
Method of measurement: Using the ELISA method

14

Description: C-Reactive Protein (CRP)
Timepoint: Before the intervention and 8 weeks after the intervention
Method of measurement: Using the ELISA method

15

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

16

Description: Thyroid stimulating hormone
Timepoint: Before the intervention and 8 weeks after the intervention
Method of measurement: Using the ELISA method

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

3

Description: Intervention group 2: resistance interval 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 2 .30” rest between sets. They will also take a placebo capsule containing oral paraffin weekly
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 interval resistance group and will consume 50,000 IU of vitamin D capsules once a week.
Category: Treatment - Other

5

Description: Intervention group 3: running interval group will perform 8 weeks and three times a week of high intensity interval running training consisting of 12 x 1-min running bouts at 80-90% HRmax interspersed with 1-min active recovery at 50%HRmax. They will also take a placebo capsule containing oral paraffin weekly.
Category: Treatment - Other

6

Description: Intervention group 5: Subjects in this group will have 8 weeks of high intensity interval running training similar to the interval running 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

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

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.

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General information

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