Compression the effects of pilates traning and the dill supplemention (Anethum graveolens ) on serum Irisin levels, Insulin, glucose, insulin resistance and body composition in overweight and obese woman
comparison the effects of Pilates training and dill supplementation on glucose, Insulin, Irisine and insulin resistance in overweight and obese women.
Design
A randomized controlled clinical trial with factorial groups, triple blinded
Settings and conduct
In this study, 40 overweight and obese women will be selected purposefully and were randomly divided into 4 groups (Pilates + dill, Pilates + placebo, dill and placebo). Pilates training will held at sport gym. Blood samples and body composition will be measured 24 hours before and 48 hours after the fasting intervention. participants in this study will be randomized by Throwing the dice
Participants/Inclusion and exclusion criteria
inclusion criteria:
female gender; age of 20-45 years old; BMI>25
exclusion criteria
past medical history; addiction; pregnancy; being menopause; participating in extra sport classes .
Intervention groups
intervention group1: Pilates + dill Supplementation: (n = 10): Consume (1.1 g) before each meal for six weeks, and do 6 weeks of Pilates training from 16 to 17:30 PM.
intervention group2: Pilates + Placebo (n=10) Take a placebo capsule containing starch before each meal and will practice Pilates (for six weeks).
intervention group3: Prior to each meal, taking a capsule containing 1.1 g of dill powder for six weeks.
Control group: one capsule (1.1 g starch per capsule) filled with edible green starch flour content before any breakfast, lunch, dinner time.
Main outcome variables
Irisin;
insulin resistance
insulin
glucose
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191111045412N1
Registration date:2020-02-22, 1398/12/03
Registration timing:prospective
Last update:2020-02-22, 1398/12/03
Update count:0
Registration date
2020-02-22, 1398/12/03
Registrant information
Name
Nafiseh Nasirian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3220 3164
Email address
nafiseh.nasirian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-15, 1398/12/25
Expected recruitment end date
2020-04-13, 1399/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compression the effects of pilates traning and the dill supplemention (Anethum graveolens ) on serum Irisin levels, Insulin, glucose, insulin resistance and body composition in overweight and obese woman
Public title
The effect of Pilates training and the dill Supplement on obesity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being female
Being at the age of 20-45 years old
BMI>25
Exclusion criteria:
Past medical history of an underlying disease
addiction
menopose
Age
From 25 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants in this study was randomized by throwing the dice
Blinding (investigator's opinion)
Triple blinded
Blinding description
participants, data collectors, outcome assessors are blinded
In this study, after informing all participants about their grouping and study objectives and they will give informed consent, they will randomly categorize to each group. For placebo groups, capsules of the same size and the same weight as the dill capsules will prepared. The data collectors included a laboratory expert, a blood sampler who did not know the procedure of grouping. And all participants will be treated equally on the sampling day.The statistical expert will be unaware of the participants' identities and the file containing the data and groups will given to him/her.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
IR.BUMS.REC.1397.129
Health conditions studied
1
Description of health condition studied
over weight and obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
serum irisin level
Timepoint
6 weeks after intervention starts
Method of measurement
elisa kit(CK-E90905, Made in USA)
2
Description
insulin resistance
Timepoint
6 weeks after intervention starts
Method of measurement
HOMA-IR formula
3
Description
Body composition
Timepoint
6 weeks after intervention starts
Method of measurement
Body composition including weight, body mass index, percentage of fat, protein, water and bone density of body, fitness score measured by Body composition analyzer made by South Korea
4
Description
glucose
Timepoint
6 weeks after intervention starts
Method of measurement
Pars Azmoon kit
5
Description
insulin
Timepoint
6 weeks after intervention starts
Method of measurement
insulin kit of Elecsys andcobas (12179113001v11)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Pilates + dill Supplementation: (n = 10): Consume (1.1 g) before each meal for six weeks, and do 6 weeks of Pilates training from 16 to 17:30 PM.
Category
Treatment - Other
2
Description
Intervention group2: Pilates + Placebo (n=10) Take a placebo capsule containing starch before each meal and will practice Pilates (for six weeks).
Category
Treatment - Other
3
Description
Intervention group 3: Prior to each meal, taking a capsule containing 1.1 g of dill powder for six weeks.
Category
Treatment - Drugs
4
Description
Control group: one capsule (1.1 g starch per capsule) filled with edible green starch flour content before any breakfast, lunch, dinner time.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tak Andam gym center
Full name of responsible person
Nafiseh Nasirian
Street address
Shabanie blvd
City
Birjand
Province
South Khorasan
Postal code
9748564589
Phone
+98 56 3241 4476
Email
nafiseh.nasirian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Tooba Kazeni
Street address
Ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
public-r@bums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
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
Birjand University of Medical Sciences
Full name of responsible person
Nafiseh Nasirian
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
A09 block, Imam Ali Town, Birjand
City
Birjand
Province
South Khorasan
Postal code
9715975389
Phone
+98 56 3220 3164
Fax
Email
nafiseh.nasirian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nafiseh Nasirian
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
A09 block, Imam Ali Town, Birjand
City
Birjand
Province
South Khorasan
Postal code
9715975389
Phone
+98 56 3220 3164
Fax
Email
nafiseh.nasirian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Nafiseh Nasirian
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
A09 block, Imam Ali Town, Birjand
City
Birjand
Province
South Khorasan
Postal code
9715975389
Phone
+98 56 3220 3164
Fax
Email
nafiseh.nasirian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Title and more details about the data/document
Part of the data such as information about the primary outcome
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
It will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
all researchers working in academic and scientific institutions
From where data/document is obtainable
nafiseh.nasirian@gmail.com
What processes are involved for a request to access data/document
after reading their request as soon as possible if the researcher find out the request valid