Protocol summary

Summary
The main purpose of this research was to investigate the effect of six-week aerobic exercise with moderate intensity and consumption of 80 mg nano-curcumin after breakfast on Interleukin 6, Interleukin 10, Tumor necrosis factor-alpha, Interleukin 1B, Brain-derived neurotrophic factor, Depression, Medium and short-term memory in 60-65 year-old women with metabolic syndrome. nano-curcumin consumption was double blinded. Participants were randomly divided into 4 groups of metabolic syndrome exercise plus nano-curcumin, metabolic syndrome exercise, metabolic syndrome nano-curcumin, and metabolic syndrome control. During the first week metabolic syndrome exercise+ nano-curcumin group and metabolic syndrome exercise participated in three sets of twelve-minute aerobic exercise training with treadmill. They also had 5-minute rest parts between the sets. One minute was added to the duration of exercise sets on a weekly basis. Blood samples were conducted before and after six-week interventions. Interleukin 6, Interleukin 10, Tumor necrosis factor-alpha, Interleukin 1B, Brain-derived neurotrophic factor levels were measured by Enzyme-linked Immunosorbent Assay method and memory test were conducted with a Picture recall test and Digit span Memory test. Also the amount of depression was measured with Beck Depression Test-Questionnaire. Exclusion criteria: Being absent for 3 sessions during 6 weeks; Not consuming (nano-curcumin) according to the instructions.

General information

Acronym
-----------
IRCT registration information
IRCT registration number: IRCT2017082335857N1
Registration date: 2017-11-16, 1396/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-16, 1396/08/25
Registrant information
Name
Ali Osali
Name of organization / entity
Bonab University
Country
Iran (Islamic Republic of)
Phone
+98 24 3376 4929
Email address
osaliphd@bonabu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Six-Week Aerobic Exercise and consumption of nano-curcumin on Interleukin 6, Interleukin 10, Tumor necrosis factor-alpha, Interleukin 1B, Brain-derived neurotrophic factor, Depression, Medium and short-term memory in 60-65 Years Old Women with metabolic syndrome.
Public title
The Effect of Six-Week Aerobic Exercise and consumption of nano-curcumin on Interleukin 6, Interleukin 10, Tumor necrosis factor-alpha, Interleukin 1B, Brain-derived neurotrophic factor, Depression, Medium and short-term memory in 60-65 Years Old Women with metabolic syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being female; Being 60-65 years old; and metabolic syndrome; Not doing regular exercise. Exclusion criteria: Being absent for 3 sessions during 6 weeks; Not consuming (nano-curcumin) according to the instructions.
Age
From 60 years old to 65 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study randomization was performed using sealed envelopes

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University Medical Sciences
Street address
Semnan Province, Semnan, Basij Blvd
City
Semnan
Postal code
3514799442
Approval date
2017-07-12, 1396/04/21
Ethics committee reference number
IR.SEMUMS.REC.1396.107

Health conditions studied

1

Description of health condition studied
syndrome metabolic
ICD-10 code
----------
ICD-10 code description
---------------

Primary outcomes

1

Description
IL6
Timepoint
Before intervention and after six week intervention
Method of measurement
pg- Enzyme-linked Immunosorbent Assay

2

Description
IL10
Timepoint
Before intervention and after six week intervention
Method of measurement
pg- Enzyme-linked Immunosorbent Assay

3

Description
IL1B
Timepoint
Before intervention and after six week intervention
Method of measurement
pg- Enzyme-linked Immunosorbent Assay

4

Description
TNF-a
Timepoint
Before intervention and after six week intervention
Method of measurement
pg- Enzyme-linked Immunosorbent Assay

5

Description
BDNF
Timepoint
Before intervention and after six week intervention
Method of measurement
pg- Enzyme-linked Immunosorbent Assay

Secondary outcomes

1

Description
Short-Term Memory
Timepoint
Before intervention and after six week intervention
Method of measurement
Powerpoint Software-Recall Numbers Test

2

Description
Medium-Term Memory
Timepoint
Before intervention and after six week intervention
Method of measurement
Powerpoint Software-Picture Recall Test

3

Description
Depression
Timepoint
Before intervention and after six week intervention
Method of measurement
Beck Depression Test- Questionnaire

Intervention groups

1

Description
Intervention group: Drug group, nano-curcumin was taken once a day (morning) pill - 80 mg for six weeks. The nano-curcumin manufacturing license used in the study was for the Exquisite Nano Sina Company and the location of the building was at the Minoo Iran Pharmacy Company.
Category
Treatment - Drugs

2

Description
Intervention group: Exercise and Drug group, six-week aerobic exercise with moderate intensity during the first week MECU group and ME participated in three sets of twelve-minute aerobic exercise training with treadmill, they also had 5-minute rest parts between the sets. One minute was added to the duration of exercise sets weekly basis. nano-curcumin was taken once a day (morning) pill - 80 mg for six weeks. The nano-curcumin manufacturing license used in the study was for the Exquisite Nano Sina Company and the location of the building was at the Minoo Iran Pharmacy Company.
Category
Treatment - Other

3

Description
Intervention group: Exercise group, six-week aerobic exercises with moderate intensity During the first week MECU group and ME participated in three sets of twelve-minute aerobic exercise training with treadmill. They also had 5-minute rest parts between the sets. One minute was added to the duration of exercise sets weekly basis.
Category
Treatment - Other

4

Description
Control group: This group did not received any interventions within 6 weeks of the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Bonyadshahid and Umorisargharan ostan Zanjan
Full name of responsible person
Ali Osali
Street address
Bonyadshahid and Umorisargharan ostan Zanjan,Zanjan, Zanjan
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for reserch of University of Bonab
Full name of responsible person
Dr.Hossein Ghaforian
Street address
Bonab University
City
Bonab
Grant name
-------
Grant code / Reference number
--------
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reserch of University of Bonab
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Azarbaijan Shahid Madani
Full name of responsible person
Dr.Karim Azali Alamdari
Position
Assistant Professor of Azarbaijan Shahid Madani University
Other areas of specialty/work
Street address
Azarbaijan Shahid Madani University, Azar Shahr, Azarbaijan Sharghi
City
Azar Shahr
Postal code
Phone
+98 41 3772 4829
Fax
Email
azalof@yahoo.com; azalof@gmail.com; azaiof@yahoo.com;
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Bonab
Full name of responsible person
Dr.Ali Osali
Position
Phd
Other areas of specialty/work
Street address
Bonab University, Bonab, Azarbayjan Sharghi
City
Bonab
Postal code
5551761167
Phone
+98 41 3772 4829
Fax
+98 41 3774 0800
Email
osalialiphd@gmail.com;
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Dr.Karim Azali Alamdari
Position
Phd
Other areas of specialty/work
Street address
Azarbaijan Shahid Madani University, Azar Shahr, Azarbaijan Sharghi
City
Azar Shahr
Postal code
Phone
00
Fax
Email
azalof@yahoo.com; azalof@gmail.com; azaiof@yahoo.com;
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...