The effect of aerobic training with silymarin consumption on some cardiovascular risk factors in men with type 2 diabetes
Design
The study population consists of all male diabetic patients in Gachsaran city with 3 years of diabetes history who participate in the research voluntarily and are randomly divided into 4 research groups based on weight.
Settings and conduct
At first, by announcing a call in the diabetic patients’ associations and other places of Gachsaran city, all types of diabetic patients were invited in an announcement. Then, in a briefing session, the potential risks and benefits of participating in the present study were explained to all participants. to make them unable to do physical activity were selected.all subjects competed the consent form.Subjects were randomly divided into 4 groups, including: (1) control plus placebo (coated tablet containing wheat flour), (2) aerobic training , (3) aerobic training plus silymarin supplementation, and (4) silymarin consumption.Silymarin receiving groups consumed coated tablets containing 140 mg / kg silymarin daily (one after breakfast and one after dinner) by the Livergol brand manufactured by GolDarou Company
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diabetic history 3 years and more, age 40 to 50 years;
Exclusion criteria: high blood pressure, smoking, regular exercise in the last 2 years
Intervention groups
The control group has no exercise activity for 2 months and also does not take silymarin. The aerobic training group (2) trained for eight weeks, three sessions per week and each session for 20-45 minutes at an intensity of 60 to 85% of the reserved heart rate. Both silymarin groups (3) take two 140 mg coated silymarin tablets daily. Aerobic training group plus silymarin (4) exercise for 2 months and use silymarin tablets.
Main outcome variables
Triglyceride; Cholesterol
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046506N3
Registration date:2020-06-02, 1399/03/13
Registration timing:retrospective
Last update:2020-06-02, 1399/03/13
Update count:0
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Ali Khajehlandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3233 5910
Email address
a.khajehlandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-10, 1398/10/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic training with silymarin consumption on some cardiovascular risk factors in men with type 2 diabetes
Public title
The effect of aerobic training with silymarin consumption on some cardiovascular risk factors in men with type 2 diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients who have had a minimum of 3 years of diabetes
Age of participants 40 - 50 years
Exclusion criteria:
The lack having the effects of diabetes, like diabetic foot ulcers
The lack history of heart disease and lung disease
The lack regular exercise of athletic activity in the last two years
The lack of tobacco in the last six months
Age
From 40 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was carried out based on permuted block randomization, using random allocation software. Considering 60 subjects in the sample and 4 treatment period, 15 four-odd blocks for randomization are considered.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University ,Gachsaran Branch
Street address
Daneshjo Blvd.,Gachsaran
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
63876-75818
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
IR.IAU.IAUG.REC.1398.005
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Triglyceride
Timepoint
Two months after intervention
Method of measurement
Blood serum
Secondary outcomes
1
Description
Weight Lose
Timepoint
Two months after training
Method of measurement
By Scale
Intervention groups
1
Description
Intervention group: Three sessions of exercise per week and each session 20-45 minutes with intensity of 60 to 85% of heart rate reserve, for eight weeks
Category
Other
2
Description
Intervention group: Use silymarin for 8 weeks daily in two coats of 140 mg silicarin coated tablets (one after breakfast and one after dinner) with the Lever Flower brand manufactured by Gul Daroo Company (economic code IRC12280250372).
Category
Other
3
Description
Intervention group: Three sessions of exercise per week, each session of 20-45 minutes, with 60-85% heart rate reserve plus silymarin for 8 weeks daily, two 140 mg silicarin-coated tablets (one after breakfast and one with breakfast). After Dinner) By Liver Flower brand made by Gol Daroo Company (economic code IRC12280250372)
Category
Other
4
Description
Control group: Take a coated tablet containing wheat flour
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, Gachcaran Branch
Full name of responsible person
ALI Khajehlandi
Street address
No.12, North Tenth Ave., Valiasr Blvd., Gachsaran
City
Gachcaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797786
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Islamic Azad University Gachsaran Branch
Full name of responsible person
Amin Mohammadi
Street address
No.31,Western Eighth Ave., shahed Blvd.,Razmandegan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581796481
Phone
+98 74 3233 5333
Email
Amin.mohammadi8@gmail.com
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, Islamic Azad University Gachsaran Branch
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sport Sciences
Street address
No.12, North Tenth Ave., Valiasr Blvd., Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sport Sciences
Street address
No.12, North Tenth Ave., Valiasr Blvd., Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Gachsaran Branch
Full name of responsible person
Ali Khajehlandi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sport Sciences
Street address
No.12, North Tenth Ave., Valiasr Blvd., Karconan Town
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581797836
Phone
+98 74 3233 5910
Email
a.khajehlandi@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