Protocol summary

Study aim
Evaluation of the effect of eight weeks of combined training and thyme supplementation on ANGPTL3 ANGPTL4, ANGPTL8, lipid profile and some cardiovascular risk factors in inactive men
Design
This study is a double-blind factorial clinical trial. The target population is 40 inactive men, who are randomly divided into 3 intervention groups and 1 control group. Intervention and control groups receive 500 mg of Zataria multiflora supplement or placebo daily for 8 weeks. Combined exercise program 8 weeks, 3 sessions per week, 30 minutes of aerobic exercise with an intensity of 60 to 70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions.
Settings and conduct
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 in the sport club and blood sampling by the sampler the laboratory is done.
Participants/Inclusion and exclusion criteria
Admission: Failure to participate in regular exercise during the last year, no type 2 diabetes, cardiovascular disease and hypertension and disease systemic and malignant, not consuming alcoholic beverages and drugs or supplements food, age range 25 to 37 years, lack of physical restraint in order participate in sports exercises, sign informed consent. Exit: Absence more than one session in the exercise program, allergies to Zataria multiflora supplements.
Intervention groups
After filling in the individual consent form, the subjects are divided into four groups of 10 people: placebo, Zataria multiflora supplement, aerobic exercise, aerobic exercise + Zataria multiflora supplement.
Main outcome variables
Angiopoietin-like protein-3 (ANGPTL3) ; Angiopoietin-like protein 4 (ANGPTL4); Angiopoietin-like protein8 (ANGPTL8) ; Tri glyceride(TG); Total cholesterol; C-Ractive Protein(CRP)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211107052994N1
Registration date: 2021-11-25, 1400/09/04
Registration timing: prospective

Last update: 2021-11-25, 1400/09/04
Update count: 0
Registration date
2021-11-25, 1400/09/04
Registrant information
Name
Arash Sadeghi
Name of organization / entity
Islamic azad university science and research
Country
Iran (Islamic Republic of)
Phone
+98 21 4499 7017
Email address
arash12601@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-26, 1400/09/05
Expected recruitment end date
2022-01-05, 1400/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of combined training with Zataria multiflora supplementation on ANGPTL3, ANGPTL4, ANGPTL8, lipid profile and some cardiovascular risk factors in inactive men
Public title
The effect of combined training with Zataria multiflora supplementation on lipid profile and some cardiovascular risk factors in inactive men
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
No cardiovascular disease and diabetes Not participating in physical activity in the past year No physical and medical restrictions for exercising
Exclusion criteria:
Alcohol and drug use Allergy toZataria multiflora supplements Taking supplements or medications in the last 6 months
Age
From 25 years old to 37 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the error caused by the knowledge of the participants and the researcher to the type of treatment received and its possible effect on the research result,we do the study in two blind directions.Placebo andZataria multiflora supplements are placed inside the capsule in exactly the same way. As a result, 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 - Research Sciences Unit
Street address
13th floor, headquarters of the Ministry of Health, Treatment and Medical Education, Sima Iran St., Gharb Town
City
Tehran
Province
Tehran
Postal code
1467765681
Approval date
2021-11-04, 1400/08/13
Ethics committee reference number
IR.IAU.SRB.REC.1400.177

Health conditions studied

1

Description of health condition studied
Inactive men
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Angiopoietin-like protein 3(ANGPTL3)
Timepoint
First, the end of the study
Method of measurement
Elisa Kit

2

Description
Angiopoietin-like protein 4(ANGPTL4)
Timepoint
First, the end of the study
Method of measurement
Elisa Kit

3

Description
Angiopoietin-like protein 8(ANGPTL8)
Timepoint
First, the end of the study
Method of measurement
Elisa Kit

4

Description
Total cholesterol
Timepoint
First, the end of the study
Method of measurement
Plasma serum

5

Description
Tri glyceride(TG)
Timepoint
First, the end of the study
Method of measurement
Plasma serum

6

Description
C-Reactive Protein (CRP)
Timepoint
First, the end of the study
Method of measurement
Bionic Kit

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Failure to participate in the combined exercise program, consumption of placebo capsules for 8 weeks with the content of wheat flour made by Gol Daroo company in addition to daily life activities
Category
Placebo

2

Description
Intervention group: Zataria multiflora supplement group (taking Zataria multiflora supplement, not participating in aerobic exercise program) for 8 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 training group + Zataria multiflora supplement (taking Zataria multiflora supplement and simultaneously participating in the combined training program) for 8 weeks and 500 mg of thyme supplement made by Gol Darob Company daily, in addition to the training program, including 8 weeks of combined training, 3 sessions per week. Includes 30 minutes of aerobic exercise 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 and cool down for 7 minutes.
Category
Prevention

4

Description
Intervention group: Combined exercise group. The training program includes 8 weeks of combined training, 3 sessions per week. 30 minutes of aerobic exercise with an intensity of 60 to 70% of maximum heart rate and 30 minutes of resistance training with a maximum intensity of 10 repetitions are designed. Before and after each exercise session, warm up for 10 minutes and cool down for 7 minutes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Jila Abbaspour
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Fax
+98 21 8862 2675
Email
iumspr@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ruhollah Dehghani Firoozabadi
Street address
Shohada Hesarak Boulevard, University Square, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4735 3501
Fax
+98 21 4486 7212
Email
safari@damavandiau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Azad University - Deputy of research and technology
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
Islamic Azad University
Full name of responsible person
Arash Sadeghi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No.36 ,negin gharb town, highway ardestani
City
Tehran
Province
Tehran
Postal code
1998684911
Phone
+98 21 4499 7017
Fax
Email
arash12601@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mandana Gholami
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Shohada Hesarak Boulevard, University Square, Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Email
gholami_man@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Sadeghi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No.36, negin gharb town, highway ardestani
City
Tehran
Province
Tehran
Postal code
1998684911
Phone
+98 21 4499 7017
Fax
Email
arash12601@yahoo.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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...