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Effects of Saffron (Crocus sativus L.) supplementation and Combined Training on Physiological Regulators in obese men with T2DM

Protocol summary

Study aim
The effect of saffron supplementation and Combined Training on Physiological and biochemical markers in obese men with type 2 diabetes
Design
volunteers first register and then subjects selected purposefully based on inclusion criteria, and randomly divided into Four groups of Combined Training, saffron, Combined Training + saffron and control.
Settings and conduct
Subjects in Combined Training groups and saffron + Combined Training groups performed the Combined Training protocol for twelve weeks (3 days per week). also Subjects in the saffron and Combined Training + saffron groups consumed one tablet (100 mg) of saffron daily for twelve weeks. All exercises were performed at a gym, also Blood samples were evaluated before and after interventions in the laboratory.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 30-50 years, BMI > 30 kg/m2, fasting blood glucose ≥ 126 mg/dL, HbA1C ≥ 6.5%. Exclusion criteria: use insulin, having cardiovascular diseases, musculoskeletal disorders, liver disease, kidney disease, and thyroid dysfunction. having regular physical activity in the past year, Not taking dietary supplements, Sensitivity to saffron.
Intervention groups
Four groups of Combined Training, saffron, Combined Training + saffron and control.
Main outcome variables
Insulin, testosterone, Nitric oxide, hs-CRP, TNF-α, IL-6, IL-10, adiponectin, leptin, Chemerin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190731044398N4
Registration date: 2020-07-25, 1399/05/04
Registration timing: retrospective

Last update: 2020-07-25, 1399/05/04
Update count: 0
Registration date
2020-07-25, 1399/05/04
Registrant information
Name
Babak Hooshmand Moghadam
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 0540
Email address
babak.hooshmand@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-30, 1399/03/10
Expected recruitment end date
2020-06-14, 1399/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Saffron (Crocus sativus L.) supplementation and Combined Training on Physiological Regulators in obese men with T2DM
Public title
Effects of Saffron (Crocus sativus L.) supplementation and Combined Training in obese men with T2DM
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age 30-50 years BMI > 30 kg/m2 fasting blood glucose ≥ 126 mg/dL HbA1C ≥ 6.5%
Exclusion criteria:
use insulin having cardiovascular diseases, musculoskeletal disorders, liver disease, kidney disease, and thyroid dysfunction having regular physical activity in the past year Not taking dietary supplements Sensitivity to saffron
Age
From 30 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, simple randomization method with random number Table method was used. This table contains a bunch of numbers that are randomly drawn in the form of a table without a specific pattern and order. The numbers directions(Left, right, up, down) were first determined by the researcher to read the numbers and then the numbers were considered for different research groups. In the next step, the researcher randomly placed on one of the numbers and moved in the present direction and recorded the numbers for that direction in the target group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, participants are unaware of the group assigned to themselves and other participants. experts in laboratory analysis are also unaware of the type of intervention and the participating groups.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ferdowsi University of Mashhad
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Approval date
2019-11-13, 1398/08/22
Ethics committee reference number
IR.UM.REC.1399.009

Health conditions studied

1

Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

2

Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
obesity

Primary outcomes

1

Description
Fasting insulin
Timepoint
Before and after intervention
Method of measurement
Autoanalyzer kit

2

Description
Serum levels of testosterone
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

3

Description
Serum levels of Nitric oxide
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

4

Description
Serum levels of hs-CRP
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

5

Description
Serum levels of TNF-α
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

6

Description
Serum levels of IL-6
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

7

Description
Serum levels of IL-10
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

8

Description
Serum levels of adiponectin
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

9

Description
Serum levels of leptin
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

10

Description
Serum levels of Chemerin
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method

Secondary outcomes

1

Description
fat mass
Timepoint
Before and after intervention
Method of measurement
bioelectrical impedance device

2

Description
fat free mass
Timepoint
Before and after intervention
Method of measurement
bioelectrical impedance device

3

Description
Dietary intake
Timepoint
Before and after intervention
Method of measurement
Food record questionnaire

Intervention groups

1

Description
Intervention group: The training group performed 12 weeks and each week 3 sessions of combined training (Resistance training, Aerobic training). Resistance training (Three sets / six exercises / 60-90-second rest between each set/ 90-120-second rest between each exercise) which contained leg press, bench press, leg extension, lat pulldown, lying leg curl, and shoulder press. the aerobic training protocol was 1×10 minutes exercise with one minute active rest between the sets.
Category
Prevention

2

Description
Intervention group: The saffron group consumed one pill of 100 mg of saffron for 12 weeks.
Category
Prevention

3

Description
Intervention group: the saffron + training group performed a combined training program (Resistance training, Aerobic training) for 12 weeks and 3 sessions per week and consumed one pill of 100 mg of saffron daily. Resistance training (Three sets / six exercises / 60-90-second rest between each set/ 90-120-second rest between each exercise) which contained leg press, bench press, leg extension, lat pulldown, lying leg curl, and shoulder press. the aerobic training protocol was 1×10 minutes exercise with one minute active rest between the sets.
Category
Prevention

4

Description
Control group: The control group did not perform combined training and did not consume saffron.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Tehran
Full name of responsible person
Abbas Ali Gaeini
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
aagaini@ut.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research, Ferdowsi University
Full name of responsible person
amir rashidlamir
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Email
amir.rashidlamir@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Ferdowsi 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
Ferdowsi University of Mashhad
Full name of responsible person
amir rashidlamir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Email
amir.rashidlamir@um.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
amir rashidlamir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Email
amir.rashidlamir@um.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Babak Hooshmand Hoghadam
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Ferdowsi University of Mashhad, Azadi Sq., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948974
Phone
+98 51 3880 5000
Email
b.hooshmand.m@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Publication of protocol study in form of the article and also data publication in the original article. The total potential data can be shared after unidentifiable subjects.
When the data will become available and for how long
6 months after the publication of results
To whom data/document is available
All researchers who have access to clinical trials databases.
Under which criteria data/document could be used
The only way for using the data is after the publication of the article in the indexed ISI journal.
From where data/document is obtainable
Via database websites such as PubMed and google scholar and via email address: b.hooshmand.m@gmail.com
What processes are involved for a request to access data/document
The original article reaches the requestor by email within a maximum of one week.
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