Comparison of the effect of short-term supplement of garlic and ginger on the respons of C-reactive protein to a progressive exercise session in overweight inactive middle-aged women
The aim of the research is to compare the short-term supplemental effect of garlic and ginger on CRP response to a progressive resistance training session in overweight inactive middle-aged women.
Design
Clinical trial with control group, with parallel group, single blind, simple randomized, phase 3 on 21 volunteers.
Settings and conduct
The population of participants is overweight middle-aged women of Chalus city
Participants/Inclusion and exclusion criteria
The participants must be overweight (BMI between 26 and 30) and in the age group of 35 to 55 years. Among other conditions, there is no history of sports activity in the last 6 months and no disease, no refusal or any sensitivity to the use of supplements. is intended.
Intervention groups
Taking garlic or ginger supplements in two groups of 7 people, a control group of 7 people with placebo and exercise training intervention in all 3 groups
Main outcome variables
The independent variables include exercise and garlic and ginger supplements. The dependent variable is C-reactive protein or CRP response.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230805059037N1
Registration date:2023-09-10, 1402/06/19
Registration timing:retrospective
Last update:2023-09-10, 1402/06/19
Update count:0
Registration date
2023-09-10, 1402/06/19
Registrant information
Name
Fatemeh Soltanifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5235 6473
Email address
soltanifarfatemeh1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-12, 1402/05/21
Expected recruitment end date
2023-08-17, 1402/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of short-term supplement of garlic and ginger on the respons of C-reactive protein to a progressive exercise session in overweight inactive middle-aged women
Public title
Effect of short-term supplement of garlic and ginger on the respons of C-reactive protein to a progressive exercise session
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
BMI(body mass index) in the overweight range of 26 to 30 years old
Exclusion criteria:
Using steroidal and non-steroidal anti-inflammatory drugs for at least 2 months before
History of sports activity in the last 6 months
Absence of diseases
Refusal or any sensitivity to taking the desired supplements
Age
From 35 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method with the entry criteria of BMI of the participants who must be in the overweight range of 26 to 30. After determining the BMI of the people from a certain BMI to below, a simple random draw of 3 people, 3
people, and 3 envelopes number 1 Number 2 and number 3 are separated for 3 ginger supplement groups - garlic supplement group - placebo group. The lottery is done by someone other than the researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, the participants were kept blind. In this way, the purpose and reason for conducting the research will be explained to the participants in the briefing session, an informed consent form will be obtained, but which garlic or ginger supplement or placebo will the participants take? They will not be informed.
Placebo
Used
Assignment
Parallel
Other design features
A semi-experimental applied study with a pre-test, post-test research design with a control group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Islamic AzadUniversity .Tunkabon branch
Street address
Killometer 3 Chalus-Wali Abad roadTtunkabon Islamic Azad University complex
City
Tunkabon
Province
Mazandaran
Postal code
4684161167
Approval date
2023-08-14, 1402/05/23
Ethics committee reference number
IR.IAU.TON.REC.1402.042
Health conditions studied
1
Description of health condition studied
Checking the level of C-reactive protein or CRP
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of change in the blood level of C-reactive protein or (CRP)
Timepoint
Blood measurement of C-reactive protein or (CRP) level before starting the intervention, 14 days after taking garlic or ginger supplement.
Method of measurement
Measurement in a blood sample (blood test)
Secondary outcomes
1
Description
level of C-reactive protein or (CRP)
Timepoint
Blood measurement of C-reactive protein or (CRP) level before starting the intervention, 14 days after taking garlic or ginger supplement.
Method of measurement
Measurement in a blood sample (blood test)
Intervention groups
1
Description
Control group: Control group: First intervention group: Ginger supplement group produced by Gol Daro Pharmaceutical Factory (n=7) which is taken in the form of 1 gram of dry ginger in the form of 2 capsules of 500 mg with 2 meals, breakfast and lunch with 250 ml of water. The second experimental group: the garlic supplement group produced by Gol Daro pharmaceutical factory (n=7), which is consumed in the form of 1 gram of garlic powder in the form of 2 capsules of 500 mg with 2 meals, breakfast and lunch, along with 250 ml of water for two days.
Category
Treatment - Drugs
2
Description
Control group: The third experimental group: the placebo group will take 1 gram of starch powder produced by Gol Daro pharmaceutical factory in the form of 2 capsules of 500 mg with 2 meals of breakfast and lunch with 250 ml Water.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health and Treatment network of Chalus city - Ayatollah Taleghani Hospital
Full name of responsible person
Fatemeh Soltanifar
Street address
Salamat Alley ,Imam Street, Health Network and Taleghani Hospital
City
Chalus
Province
Mazandaran
Postal code
4661619373
Phone
+98 11 5219 0413
Email
behdashtchalos@yahoo.com
Web page address
http://www.hcch.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samaneh Damanpak
Street address
Kilometer 3 Chalus Waliabad road،TunekabonIslamic Azad University complex
City
Tunekabon
Province
Mazandaran
Postal code
4684161167
Phone
+98 930 545 5041
Email
sdamanpak@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Fatemeh Soltanifar
Position
Employee of the Ministry of Health
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.2 ،shalizr Alley.Shalizar sharghi Ave.Nowshahr
City
Nowshahr
Province
Mazandaran
Postal code
4651114875
Phone
+98 11 5235 6473
Email
soltanifarfatemeh1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Soltanifar
Position
Employee of the Ministry of Health
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.2 ،shalizr Alley.Shalizar sharghi Ave.Nowshahr
City
Nowshahr
Province
Mazandaran
Postal code
4661619373
Phone
+98 11 5235 6473
Email
soltanifarfatemeh1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Soltanifar
Position
کارمند وزارت بهداشت و درمان
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
No.2 ،shalizr Alley.Shalizar sharghi Ave.Nowshahr
City
Nowshahr
Province
Mazandaran
Postal code
4661619373
Phone
+98 11 5235 6473
Email
soltanifarfatemeh1@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
Undecided - It is not yet known if there will be a plan to make this available