Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Siirtoin1, eutoxin-1,Inflammatory and anti-inflammatory markers, antioxidant markers
General information
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Reason for update
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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)
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Acronym
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IRCT registration information
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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
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Registration date
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2021-08-22, 1400/05/31
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-08-21, 1400/05/30
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Expected recruitment end date
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2021-09-21, 1400/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of high intensity interval resistance training and vitamin D intake onvitamin D th and anti inflammatory-oxidative status in overweight women
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 23 years old to 29 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
78
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-04-27, 1400/02/07
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Ethics committee reference number
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IR.IAU.SARI.REC.1400.004
Health conditions studied
1
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Description of health condition studied
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Overweight
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ICD-10 code
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E66.0
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ICD-10 code description
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Obesity due to excess calories
2
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Description of health condition studied
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Vitamin D deficiency
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ICD-10 code
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E50.5
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ICD-10 code description
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Vitamin D deficiency
Primary outcomes
1
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Description
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Eotaxin-1
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
2
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Description
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Sirtuin1
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
3
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Description
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interlukin10
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
4
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Description
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25- hydroxy vitamin D
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Timepoint
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Before and after interventions
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Method of measurement
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Using the ELISA method
5
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Description
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Brain-Derived Neurotrophic Factor
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
6
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Description
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Superoxide dismutase
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Laboratory methods
7
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Description
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Tumor necrosis factor alpha
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
8
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Description
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Monocyte Chemoattractant Protein 1
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
9
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Description
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Malondialdehyde
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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spectrophotometrically
10
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Description
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Homocysteine
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
11
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Description
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Total Antioxidant Capacity
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Ferric Reducing/Antioxidant Power
12
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Description
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Transforming growth factor-beta 1 (TGF-beta1)
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
13
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Description
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Vascular endothelial growth factor (VEGF)
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
14
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Description
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C-Reactive Protein (CRP)
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
15
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Description
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Adiponectin
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
16
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Description
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Thyroid stimulating hormone
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Timepoint
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Before the intervention and 8 weeks after the intervention
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Method of measurement
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Using the ELISA method
Secondary outcomes
1
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Description
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Sleep quality
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Timepoint
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Before and after interventions
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Method of measurement
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Sleep quality questionnaire
2
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Description
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Quality of Life
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Timepoint
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Before the intervention and 2 weeks after the intervention
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Method of measurement
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Quality of Life Questionnaire
Intervention groups
1
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Description
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Control group: There is no intervention in the control group and they are given placebo in a single blind manner
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Category
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Placebo
2
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Description
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Intervention group 1: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks.
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Category
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Treatment - Other
3
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Description
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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
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Category
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Treatment - Other
4
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Description
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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.
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Category
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Treatment - Other
5
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Description
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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.
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Category
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Treatment - Other
6
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sari branch, Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available