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Investigating the separate and combined effects of resistance training and cucumber (cucumis sativus) juice consumption on diabetic, lipid, oxidative and hepatic indices status of women with type 2 diabetes

Protocol summary

Study aim
Investigating the separate and combined effects of resistance training and cucumber juice consumption on the status of diabetic, lipid, oxidative and liver indicators in women with type 2 diabetes
Design
A randomized and unblinded clinical trial with intervention and control groups by using 40 subjects.
Settings and conduct
About the tests for all intervention groups: in the first session, questionnaire and measurement of height, weight and body composition, in the second session, blood sampling with 48 hours of previous rest in a fasting state followed by at least 8 hours of night sleep, in the third session , the research protocol started. Resistance exercises were performed in the gymnasium of Razi University, Kermanshah. 48 hours after the last research session, blood sampling was done again.
Participants/Inclusion and exclusion criteria
Women with type 2 diabetes with an age range of 35-70 years, lack of regular sports activity in the past six months, having a health certificate from a doctor to do sports activities, no history of any cardiovascular disease, Kidney and cancer in the last 5 years, no use of insulin and no complications of diabetes, including diabetic foot ulcers. Criteria for not entering the research: inability to perform resistance exercises, pregnancy or breastfeeding, use of drugs or supplements (such as corticosteroids and anabolic hormones)
Intervention groups
Training and Placebo group, Training and Supplement group, Supplement group and Control group.
Main outcome variables
Biochemical markers of diabetic indices; lipid profile; oxidative indices and liver enzymes

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230419057962N1
Registration date: 2023-05-23, 1402/03/02
Registration timing: retrospective

Last update: 2023-05-23, 1402/03/02
Update count: 0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
Maryam Lotfi
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 6031
Email address
m.lotfi7344@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-06, 1401/09/15
Expected recruitment end date
2023-01-06, 1401/10/16
Actual recruitment start date
2022-12-06, 1401/09/15
Actual recruitment end date
2023-01-07, 1401/10/17
Trial completion date
2023-02-26, 1401/12/07
Scientific title
Investigating the separate and combined effects of resistance training and cucumber (cucumis sativus) juice consumption on diabetic, lipid, oxidative and hepatic indices status of women with type 2 diabetes
Public title
Investigating the effects of performing resistance training and consuming cucumber juice in women with type 2 diabetes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Women with type 2 diabetes Not using Insulin and not having diabetes complications, including diabetic foot ulcers No history of any Cardiovascular, Kidney or Cancer disease in the last 5 years Lack of regular sports activity during the last six months Having a Health Certificate from a doctor to do sports activities
Exclusion criteria:
Inability to do resistance training Pregnancy or Breastfeeding Use of Drugs or Supplements (such as Corticosteroids and Anabolic hormones)
Age
From 35 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The current research is an experimental type with a pretest-posttest design and random assignment of research groups (three experimental groups and one control group). For this purpose, 40 women (35 to 70) years old with type 2 diabetes who had visited the Kermanshah Diabetes Treatment Research Center were selected and randomly divided into four groups of 10 including Training and Placebo group, Training and Supplement group, Supplement group and Control group were included.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee in biomedical research of Razi university
Street address
University Ave., Taqbostan
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Approval date
2021-12-29, 1400/10/08
Ethics committee reference number
IR.RAZI.REC.1400.092

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Biochemical markers of diabetic indicators
Timepoint
48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test)
Method of measurement
Blood sampling and evaluation of samples by laboratory kits

2

Description
Biochemical markers of lipid profile
Timepoint
48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test)
Method of measurement
Blood sampling and evaluation of samples by laboratory kits

3

Description
Biochemical markers of oxidative indices
Timepoint
48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test)
Method of measurement
Blood sampling and evaluation of samples by laboratory kits

4

Description
Biochemical markers of liver indices
Timepoint
48 hours before the start of the research (pre-test) and 48 hours after the last protocol implementation session (post-test)
Method of measurement
Blood sampling and evaluation of samples by laboratory kits

Secondary outcomes

1

Description
Height measurement
Timepoint
48 hours before the start of the protocol
Method of measurement
Yagami model gauge made in Japan

2

Description
Weight measurement
Timepoint
48 hours before the start of the protocol
Method of measurement
1. Beurer digital scale, model PS07, made in Germany, with an accuracy of 0.1 kg

3

Description
Body composition measurement
Timepoint
48 hours before the start of the protocol
Method of measurement
Zeus 9.9 plus body composition analyzer made in South Korea

Intervention groups

1

Description
Intervention groups: first group: (training and placebo group) , second group: (training and supplement group ), third group: supplement group, fourth group: control group. The first group: received eight weeks of resistance training along with 240 ml of placebo. The second group: eight weeks of resistance training and received 240 ml of cucumber juice. The third group received 240 ml of cucumber juice for eight weeks. The control group received 240 ml of placebo for eight weeks. The research protocol lasted eight weeks (24 sessions). For the preparation of the placebo, edible green dye (retg, an authorized synthetic liquid edible dye, manufactured by the Yellow Line factory, under the standard of the Food and Drug Organization (I.R.I. FDO)) was used.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Research Center of Kermanshah Province
Full name of responsible person
Mehrali Rahimi
Street address
Diabetes Research Center of Kermanshah Province, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6714673159
Phone
+98 83 3838 7027
Fax
Email
research_it@kums.ac.ir
Web page address
https://vc-research.kums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi university of Kermanshah
Full name of responsible person
Mustafa Mostafai
Street address
University Ave., Taq Bostan., Razi University., Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 3427 7605
Email
b.mostafaei@razi.ac.ir
Web page address
https://are.razi.ac.ir/deputy-of-research
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi university of Kermanshah
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
Razi University of Kermanshah
Full name of responsible person
Maryam Lotfi
Position
Phd student of Excercise Physiology
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University Ave., Taq Bostan., Razi University
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 3427 7605
Email
m.lotfi7344@gmail.com
Web page address
https://razi.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Maryam Lotfi
Position
Phd student of Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University Ave., Taq Bostan., Razi University
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 3427 7605
Email
m.lotfi7344@gmail.com
Web page address
https://razi.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Razi university of Kermanshah
Full name of responsible person
Maryam Lotfi
Position
Phd student of Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University Ave., Taq Bostan., Razi University
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Phone
+98 83 3427 7605
Email
m.lotfi7344@gmail.com
Web page address
https://razi.ac.ir/

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
Not applicable
Title and more details about the data/document
After collecting the data by the researcher, it is the responsibility of the researcher to analyze the data. The data of the participants will be analyzed without mentioning their names, and after the data analysis, an article about the research data will be printed. The data file of the participants will be kept by the researcher and the results of the data analysis will be The article format will be printed. The informed consent form of the participants will be placed with the researcher and if needed, the journal or relevant authorities will be informed. The study protocol and clinical study report will be published in the form of an article. The codes used in the analysis (code of ethics) will be written in the article.
When the data will become available and for how long
After publishing the article
To whom data/document is available
The referees of the journal in which the article is to be published
Under which criteria data/document could be used
For further review and close monitoring of published data
From where data/document is obtainable
Applicants (reviewers of the journal) can contact the main researcher of the research through the postal address: Kermanshah., Taqbestan., University Ave., Razi University., Kermanshah, or send an email to the email address m.lotfi7344@gmail.com, or contact the main researcher of the research (Maryam Lotfi) through correspondence with the number 00989032215055 to receive the desired documents or data.
What processes are involved for a request to access data/document
The referees of the desired journal can send an email to the main researcher and request that the data of the protocol be served to them(in order to publish an article in the desired magazine).
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