Protocol summary

Study aim
The effect of 12 weeks of combined training (aerobic-resistance) with thyme supplementation on RBP-4, resistin, insulin resistance and body fat percentage in overweight and obese women
Design
This study is a double-blind, factorial randomized clinical trial. The target population of 40 women is overweight and obese. The intervention and control groups receive 500 mg of thyme supplement or placebo daily for 12 weeks. The combined training program is 12 weeks, 3 sessions per week, 30 minutes of aerobic exercise with an intensity of 60 to 70% of the maximum heart rate and 30 minutes of resistance training with an intensity of 10 maximum repetitions.
Settings and conduct
The placebo and thyme supplement are placed inside the capsule in exactly the same way, participants and researchers will not be aware of the type of supplement received. Exercises are performed in a sports club and blood sampling is performed by a laboratory sampler.
Participants/Inclusion and exclusion criteria
Inclusion: Failure to participate in regular exercise during the last year, no type 2 diabetes, cardiovascular disease and hypertension and systemic and malignant diseases, no consumption of alcohol and drugs or dietary supplements , age range 20-35 Lack of physical restraint in order to participate in sports exercises, signing an informed consent.exclusion: Absence from more than one session in the exercise program, allergy to thyme supplement, forcing to take medication or other nutritional supplements, injury and inability of the subject to continue the exercise program, not participating in one of the blood sampling stages
Intervention groups
After filling in the individual consent form, the subjects are randomly divided into four groups of 10 people: placebo, thyme supplement, aerobic exercise, aerobic exercise + thyme supplement.
Main outcome variables
RBP-4, resistin, body fat percentage and insulin resistance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200812048388N1
Registration date: 2020-11-21, 1399/09/01
Registration timing: retrospective

Last update: 2020-11-21, 1399/09/01
Update count: 0
Registration date
2020-11-21, 1399/09/01
Registrant information
Name
forough darabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4489 1536
Email address
19foroughdarabi91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 12 weeks combined training (aerobic-resistance) and zataria multiflora supplementation on the levels of some inflammatory adipokines in overweight and obese women
Public title
The effect of 12 weeks of combined training (aerobic-resistance) with thyme supplement on RBP-4, resistin, insulin resistance and body fat percentage in overweight and obese women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not participating in regular exercise during the last year Not having type 2 diabetes, cardiovascular disease and high blood pressure No systemic and malignant diseases including cancer Do not consume whole drinks Do not take medication or dietary supplements during the research period Age range 35-20 Lack of physical restraint in order to participate in sports exercises Signing informed consent
Exclusion criteria:
Absence of more than one session in the exercise program Allergy or sensitivity to thyme supplement Compulsion to take medication or other nutritional supplements over a 12-week periodInjury and inability of the subject to continue the training program Failure to participate in one of the blood sampling steps (pre-test or post-test)
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Using the lottery method, the names of the subjects are written on separate papers and placed in a container, then the names of the subjects are randomly taken out and placed in the intervention group or placebo. The first 30 names in the intervention group and the rest They are in the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the error caused by the participants' and researcher's knowledge of the type of treatment received and its possible effect on the research result, we conduct a two-way study. Due to the fact that thyme supplements are placed exactly the same inside the capsule, participants and researchers are not aware of the type of supplement received.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Gholum and Research Branch
Street address
Tehran, end of Shahid Sattari Highway, University Square, Shohada Hesarak Boulevard
City
Tehran
Province
Tehran
Postal code
1477893855
Approval date
2020-11-14, 1399/08/24
Ethics committee reference number
IR.IAU.SRB.REC.1399.087

Health conditions studied

1

Description of health condition studied
Overweight and obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Retinol binding protein 4
Timepoint
First, the end of the study
Method of measurement
Kit Eliza

2

Description
Resistin
Timepoint
First, the end of the study
Method of measurement
Kit Eliza

3

Description
Insulin resistance
Timepoint
First, the end of the study
Method of measurement
Homa index

4

Description
fat percentage
Timepoint
First, the end of the study
Method of measurement
Body Analysis

Secondary outcomes

1

Description
Glucose
Timepoint
First, the end of the study
Method of measurement
Glucose Test Kit

2

Description
Insulin
Timepoint
First, the end of the study
Method of measurement
Insulin ELISA Kit

3

Description
Maximum volume of oxygen consumption
Timepoint
First, the end of the study
Method of measurement
Rockport test and formula method

4

Description
Body mass index
Timepoint
First, the end of the study
Method of measurement
kg/m2

Intervention groups

1

Description
Control group: not participating in the combined exercise program, taking placebo for 12 weeks, taking thyme-like capsules with wheat flour content, made by Gol Daroo company, in addition to daily life activities
Category
Placebo

2

Description
Intervention group: Thyme supplement group (taking omega-thyme supplement, not participating in aerobic exercise program) for 12 weeks and daily 500 mg of thyme supplement made by Gol Daroo company after breakfast with 100 ml of water and daily activities of life
Category
Prevention

3

Description
Intervention group: Combined exercise group. The training program includes 12 weeks of combined training, 3 sessions per week. 30 minutes of aerobic training with an intensity of 60 to 70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions. Before and after each exercise session, warm up for 10 minutes, respectively. And cool for 7 minutes.
Category
Prevention

4

Description
Intervention group: Combined training group + thyme supplement (taking thyme supplement and participating in the combined training program at the same time) for 12 weeks and 500 mg of thyme supplement made by Gol Darob Company daily. In addition, the training program includes 12 weeks of combined training, 3 sessions per week. Includes 30 minutes of aerobic exercise with an intensity of 60-70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions are designed and before and after each exercise session, 10 minutes of warm-up and 7 minutes of cooling are performed, respectively.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Forough Darabi
Street address
Tehran, Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
19foroughdarabi91@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Street address
End of Sattari Highway, University Square, Shohada Hesarak Boulevard
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 9827
Email
m.gholami@srbiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Faculty of Literature, Tehran University of Science and Research
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forough Darabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Punak, Mirzababaei intersection, Behesht 3, No. 10, Unit 8
City
Tehran
Province
Tehran
Postal code
1476736434
Phone
+98 21 4489 1536
Email
19foroughdarabi91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forough Darabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Punak, Mirzababaei intersection, Behesht 3, No. 10, Unit 8
City
Tehran
Province
Tehran
Postal code
1476736434
Phone
+98 21 4489 1536
Email
19foroughdarabi91@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Forough Darabi
Position
Student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Punak, Mirzababaei intersection, Behesht 3, No. 10, Unit 8
City
Tehran
Province
Tehran
Postal code
1476736434
Phone
+98 21 4489 1536
Email
19foroughdarabi91@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Not applicable
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