Effect of Pilates training and turmeric supplementation on serum sirtuin1, Klotho and quality of life in overweight middle-aged women.
Design
A randomized, double-blinded, sham controlled clinical trial with a parallel group design of 48 participants (12 person in every group)
Settings and conduct
Synchronization sessions, initial measurements, counseling and distribution of capsules and Pilates exercises will be held at the Vira Club located at Shariati Street. Blood sampling will be carried out at Iran Medical Laboratory of Tabriz. Blinding participants and researcher will be used to administer turmeric and placebo capsules by distributing capsules by third person.
Participants/Inclusion and exclusion criteria
Entry requirements include age range of 35-55 years, overweight, lack of regular exercise, no use of medication and supplements, having a regular menstrual cycle, Withdrawal conditions including the incidence of any illness and the presence of allergies to spices and the unwillingness of the subject to cooperate with the researcher
Intervention groups
1) Pilates Exercise Group: participate in Pilates practice program (3 sessions per week) for 12 weeks and receive 3 placebo tablets per day.
2) Turmeric Group: receive three tablets of 700 milligrams of turmeric receive daily for 12 weeks 20 min after eating.
3) Practice group and turmeric: The group will also conduct Pilates training sessions (three sessions per week) for 12 weeks and will consume daily three tablets of 700 mg of turmeric immediately after eating for 12 weeks Will
4) Control group: They will receive three placebo tablets a day, 20 min after eating for 12 weeks, but will not participate in the training program.
Main outcome variables
Serum sirtuin1; klotho gene and Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180218038785N1
Registration date:2018-03-15, 1396/12/24
Registration timing:prospective
Last update:2018-03-15, 1396/12/24
Update count:0
Registration date
2018-03-15, 1396/12/24
Registrant information
Name
Rahele Dolgari
Name of organization / entity
The university of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3551 7007
Email address
amirsasa@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-02, 1397/01/13
Expected recruitment end date
2018-05-03, 1397/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of 12 weeks of pilates training and turmeric supplementation on SIRT1, Klotho gene and Quality of life in middle-aged Overweight females
Public title
Effects of pilates training and turmeric supplementation on SIRT1, Klotho gene and Quality of life
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 35 to 55 years
Being Overweight( BMI: 25-30 kg/m²)
Without regular physical activity
No drug and supplementation
Having menstrual period
Exclusion criteria:
illness
allergy to spices
Unwillingness or person's cooperation
Age
From 35 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Using random numbers table, individuals were grouped into four groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is carried out in the distribution of turmeric and placebo capsules so that the third person (researcher assistant) will distribute the capsules and and the participants and researchers do not know if they are receiving capsules of turmeric or placebo.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
No 2 building, Tabriz University of Medical Sciences,Golgasht St,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.TBZMED.REC.1396.699
Health conditions studied
1
Description of health condition studied
Aging
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sirtuin1
Timepoint
Before and after the intervention (3 month later)
Method of measurement
Sirtuin 1 content will be measured by using Human Sirtuin1 ELISA kit, made by Shanghay Crystal D company.
2
Description
Serum Klotho gene
Timepoint
Before and after the intervention (3 month later)
Method of measurement
Human Klotho ELISA kit, made by Shanghay Crystal D company
3
Description
Quality of life
Timepoint
Before and after the intervention (3 month later)
Method of measurement
Quality of life questionare
Secondary outcomes
1
Description
Weight
Timepoint
Before and after intervention (3 month later)
Method of measurement
With Omron Digital Scale
2
Description
Body fat percent
Timepoint
Before and after intervention (3 month later)
Method of measurement
Using body composition analyzer
3
Description
Fat-free mass
Timepoint
Before and after intervention (3 month later)
Method of measurement
Using body composition analyzer
Intervention groups
1
Description
Intervention group (training) : Participate in 12 weeks of Pilates training (3 sessions per week with intensity of 40 -70 % maximum heart rate)
Category
Lifestyle
2
Description
Intervention group (supplement): Daily consumption of three tablets of 700 mg turmeric, 20 min after meal.
Category
Prevention
3
Description
Intervention group ( training-supplement): Participate in 12 weeks of Pilates training (3 sessions per week with intensity of 40 -70 % maximum heart rate) and daily consumption of three tablets of 700 mg turmeric, 20 min after meal.
Category
Prevention
4
Description
Control group: daily consumption of three placebo tablets of 700 mg starch, 20 min after meal.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz city health center
Full name of responsible person
Parastoo Ahmadi
Street address
Qods St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3444 0057
Email
p_ahmadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research and Technology Development of Tabriz University
Full name of responsible person
Abolgasem Jooyban
Street address
Emam Khomeini St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3110
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research and Technology Development of Tabriz 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
The University of Tabriz
Full name of responsible person
Rahele Dolgari
Position
instructor
Latest degree
Master
Other areas of specialty/work
exercise matabolism
Street address
No. 36, Aliabadi Ave., Ansarifard St., Khayam St.
City
Tabriz
Province
East Azarbaijan
Postal code
5184836546
Phone
+98 41 3289 4793
Email
R_Dolgari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Ramin Amirsasan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology and nutrition
Street address
Emam Khomeini St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3255
Email
amirsasan@tabrizu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Rahele Dolgari
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Exercise metabolism
Street address
No. 36, Aliabadi Ave., Ansarifard St., Khayam St.
City
Tabriz
Province
East Azarbaijan
Postal code
5184836546
Phone
+98 41 3289 4793
Email
R_Dolgari@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
Abuse is possible
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data file will be provided after encoding
When the data will become available and for how long
6 months after printing results
To whom data/document is available
all persons
Under which criteria data/document could be used
Use is not allowed
From where data/document is obtainable
Rahele Dolgari
What processes are involved for a request to access data/document