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The Effect of Pilates Training with Resveratrol on Serum Levels of Inflammatory Indices, Oxidative Stress and Endoplasmic Reticulum Stress in Middle-Aged Obese Women

Protocol summary

Study aim
The aim of this study is to compare the effect of Pilates training, resveratrol, and their combination on the serum levels of inflammatory Indices, oxidative stress, and endoplasmic reticulum stress in middle-aged obese women.
Design
This clinical trial study with a control group, will be conducted in phase 3 on 40 middle-aged obese women who are randomly selected. To place people in each group, Simple randomization by random allocation rule (balloting container and separate papers) is used.
Settings and conduct
Intervention Research, Karaj City, the research site is Sports Club. In this research, people who work with subjects are blinded. Since the exercise training did not have the ability to be blinded, the present study was performed in an unblinded manner. However, supplementation was blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being obese (Body mass index above 30), the Age range of 35-50 years, having an Inactive lifestyle (exercising less than 1 hour per week), and being willing to participate in the study. Exit criteria: not taking supplements and not doing training, and feeling the risk of doing the training.
Intervention groups
Control group: This group receives 500 mg starch tablets as a placebo during the intervention period. Training group: For 8 weeks, three sessions/weeks (20 to 40 minutes) training with an intensity of 14-16 on the ratings of perceived exertion. Resveratrol group: this group receives a tablet of 500 mg of resveratrol orally daily. Training+Resveratrol group: In this group the Simultaneous intervention, training, and Resveratrol, will treat with the same protocol described in the previous part.
Main outcome variables
Glucose-Regulated Protein 78 (GRP78), Tribbles homologue 3 (TRB3), Sestrin-2, Lipocalin-2, Malondialdehyde, Glutathione peroxidase and Insulin resistance index (HOMA-IR)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140415017288N11
Registration date: 2023-03-13, 1401/12/22
Registration timing: prospective

Last update: 2023-03-13, 1401/12/22
Update count: 0
Registration date
2023-03-13, 1401/12/22
Registrant information
Name
Ahmad Abdi
Name of organization / entity
Ayatollah Amoli Branch, Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 11 4321 7126
Email address
a.abdi@iauamol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Pilates Training with Resveratrol on Serum Levels of Inflammatory Indices, Oxidative Stress and Endoplasmic Reticulum Stress in Middle-Aged Obese Women
Public title
Effect of Training and Resveratrol on Middle-Aged Obese Women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Being obese (Body mass index above 30). Age range 35-50 years. Inactive lifestyle (exercise less than 1 hour per week) Being willing to participate in the study.
Exclusion criteria:
Diagnosis of other underlying diseases. Allergy to supplement use. Inability to do exercise training. Use of anti-inflammatory drugs.
Age
From 35 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
More than 1 sample in each individual
Number of samples in each individual: 10
Middle-Aged Obese Women
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, subjects are selected by Simple randomization by the random allocation rule. After determining the sample size (40 people), numbers 1 to 4 are written on 40 small separate papers (10 sheets of paper for each number) and placed in a container. Number 1 is for the Placebo Control Placebo (C), number 2 is for the Pilates Training (PT), number 3 is for the Resveratrol (RSV) group and number 4 is for the Pilates Training-Resveratrol (PTRSV). Then each sheet of paper is randomly taken out by the subjects and placed in the intervention or placebo groups, respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University - Ayatollah Amoli Branch
Street address
Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road.
City
Amol
Province
Mazandaran
Postal code
678
Approval date
2023-01-29, 1401/11/09
Ethics committee reference number
IR.IAU.AMOL.REC.1401.117

Health conditions studied

1

Description of health condition studied
Middle-Aged Obese Women
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Glucose-Regulated Protein 78 (GRP78)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

2

Description
Tribbles homologue 3 (TRB3)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

3

Description
Sestrin-2
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

4

Description
Lipocalin-2 (LCN2)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

5

Description
Malondialdehyde (MDA)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

6

Description
Glutathione peroxidase (GPx)
Timepoint
Before and after the protocol
Method of measurement
Biochemical and laboratory methods

7

Description
Insulin resistance index (HOMA-IR)
Timepoint
Before and after the protocol
Method of measurement
Biochemical, laboratory and formula methods

Secondary outcomes

empty

Intervention groups

1

Description
Control group: This group receives a 500 mg starch tablets as a placebo during the 8-week intervention period.
Category
Placebo

2

Description
Intervention group 1: Training group (in this group for eight-week, three session/weeks, the training start with 10 min warming and then 20 to 40 min training with an intensity of 14-16 ratings of perceived exertion. Also, this group receives 500 mg starch tablets as a placebo during the 8-week intervention period).
Category
Treatment - Other

3

Description
Intervention group 2: Resveratrol supplement group (this group receives a tablet of 500 mg of Resveratrol orally daily).طبقه بندی
Category
Treatment - Other

4

Description
Intervention group 3: Training+ Resveratrol supplementation group (In this group the Simultaneous intervention, training and Resveratrol supplementation, will treat with the same protocol that describe at the previous part).
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Amoli Branch, Islamic Azad University
Full name of responsible person
Ahmad Abdi
Street address
Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road.
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Fax
+98 11 4321 7009
Email
a.abdi@iauamol.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Asieeh Abbassi Daloii
Street address
Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road.
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Fax
+98 11 4321 7009
Email
abbasi.daloii@gmail.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
Proportion provided by this source
100
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
Ahmad Abdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road.
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Fax
+98 11 4321 7009
Email
a.abdi@iauamol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Barari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road.
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7126
Email
alireza54.barari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Abdi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Islamic Azad University, Ayatollah Amoli branch, Komdareh village, km 5 of the old Amol-Babol road.
City
Amol
Province
Mazandaran
Postal code
678
Phone
+98 11 4321 7124
Email
a.abdi@iauamol.ac.ir

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
Not applicable
Informed Consent Form
No - There is not 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
Information on the main outcomes will be shared.
When the data will become available and for how long
Since 2023
To whom data/document is available
All researchers
Under which criteria data/document could be used
If people email the person responsible for the plan, they can get the desired documents in the form of a file. (a.abdi58@gmail.com-09113001960)
From where data/document is obtainable
People can apply for documents through email.
What processes are involved for a request to access data/document
Maximum one week
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