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The effect of Tribulus terrestris supplementation on the nutritional, oxidative, inflammatory, and anti-inflammatory status and sport performance in runners

Protocol summary

Study aim
Determine the effect of Tribulus terrestris supplementation on the nutritional, oxidative, inflammatory, and anti-inflammatory status and sport performance in runners
Design
A double-blind controlled randomized clinical trial was designed with a sample size of 17 persons in each group. Athletes will be randomly divided into two groups using the RAS software and the placebo supplement (maltodextrin) after mating according to their VO2max and gender.
Settings and conduct
The present study will be conducted as a double-blind clinical trial which is aimed to determine the effect of Tribulus terrestris supplementation in runners of Tabriz stadiums.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range of 18 to 35 years, do running workouts for at least 3 days a week (240 minutes per week) during the last 2 years, complete health (confirmed by PAR-Q questionnaire under the supervision of a doctor), the body mass index of 18.5-25, not receiving Tribulus terrestris supplement in the last three months, not doing high-intensity interval training during the last two weeks, and willingness to cooperate in the study. Exclusion criteria: musculoskeletal injuries, smoking, alcohol consumption, hormone therapy, long-term use of drugs and dietary supplements, intake of antihypertensives, diuretics and antidiabetics, pregnancy, lactation, diabetes, anemia (Hb <13g / dl), cardiovascular disease, infectious diseases, gastrointestinal problems, malignancies, and cognitive disorders.
Intervention groups
34 recreational runners of Tabriz stadiums; two groups of intervention (Tribulus terrestris supplementation and physical activity) and control (maltodextrin supplementation and physical activity)
Main outcome variables
Nutritional status, oxidative stress, inflammatory, anti-inflammatory, and sport performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150205020965N8
Registration date: 2021-02-13, 1399/11/25
Registration timing: prospective

Last update: 2021-02-13, 1399/11/25
Update count: 0
Registration date
2021-02-13, 1399/11/25
Registrant information
Name
Parvin Dehghan
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7580
Email address
dehghanp@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-20, 1399/12/02
Expected recruitment end date
2021-03-06, 1399/12/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tribulus terrestris supplementation on the nutritional, oxidative, inflammatory, and anti-inflammatory status and sport performance in runners
Public title
The effect of Tribulus terrestris in runners
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of 18 to 35 years Do running workouts for at least 3 days a week (240 minutes per week) during the last 2 years Complete health (confirmed by PAR-Q questionnaire under the supervision of a doctor) The body mass index of 18.5-25 Not receiving Tribulus terrestris supplement in the last three months Not doing high-intensity interval training during the last two weeks Willingness to cooperate in the study
Exclusion criteria:
Musculoskeletal injuries Smoking Alcohol consumption Hormone therapy Long-term use of drugs and dietary supplements Intake of antihypertensives, diuretics and antidiabetics Pregnancy Lactation Diabetes Anemia (Hb <13g / dl) Cardiovascular disease Infectious diseases Gastrointestinal problems Malignancies Cognitive disorders
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
After stratified random matching, individuals will be divided into two groups of intervention (Tribulus terrestris supplementation and physical activity; 17 persons) and control (maltodextrin supplementation and physical activity; 17 persons) based on gender and VO2max using RAS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention group and the control group will consume two capsules of Tribulus terrestris (500 mg) and two capsules of maltodextrin (500 mg) each day respectively for two weeks, which is accompanied by high-intensity interval training. Supplement and placebo will be coded with codes 1 and 2. Until the release of the patient study results, the researcher and data analyzer will not be aware of the assigned codes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.TBZMED.REC.1399.974

Health conditions studied

1

Description of health condition studied
runners
ICD-10 code
Y93.02
ICD-10 code description
Activity, running

Primary outcomes

1

Description
Malondialdehyde
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

2

Description
Total antioxidant capacity
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

3

Description
Superoxide dismutase
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

4

Description
hs-CRP
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

5

Description
IL-6
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

6

Description
IL-10
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

7

Description
Creatine kinase
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

8

Description
Lactate dehydrogenase
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

9

Description
Sport performance
Timepoint
At baseline and two weeks after baseline
Method of measurement
questionnaire

10

Description
Ferritin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

11

Description
Serum iron
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

12

Description
Insulin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

13

Description
Glucose
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

14

Description
Insulin-like Growth Factor-1
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

15

Description
Adiponectin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

16

Description
PGC-1alpha expression
Timepoint
At baseline and two weeks after baseline
Method of measurement
pcr

17

Description
Tumor necrosis factor alpha
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

18

Description
α1-acid glycoprotein
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

19

Description
Myoglobin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

20

Description
Irisin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

21

Description
Cortisol
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

22

Description
Brain-Derived Neurotrophic Factor
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

23

Description
F2-isoprostanes
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

24

Description
8-Oxo-2'-deoxyguanosine
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

25

Description
GSH
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

26

Description
Carbonyl
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

27

Description
Nitric Oxide
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

28

Description
Neopterin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

Secondary outcomes

1

Description
Nutritional status (energy and macronutrients intake)
Timepoint
At baseline and two weeks after baseline
Method of measurement
3-days food intake record

2

Description
Body composition
Timepoint
At baseline and two weeks after baseline
Method of measurement
(BIA, BC-418 MA)

3

Description
Transferrin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

4

Description
CBC
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

5

Description
Serum iron
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

6

Description
Sleep
Timepoint
At baseline and two weeks after baseline
Method of measurement
Questionnaire

7

Description
Recovery and stress
Timepoint
At baseline and two weeks after baseline
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: The intervention group will consume two capsules of Tribulus terrestris (500 mg) each day, which is accompanied by high-intensity interval training. One of the capsules would be taken after breakfast and the other one would be taken after lunch. To ensure the supplement consumption and follow up the recreational runners' problems, the delivery of unused capsules will be requested at the end of each week. Study subjects will be asked to report any problems too. To apply the exercise protocol, the study subjects will do high-intensity interval training for five days each week (during two weeks).
Category
Prevention

2

Description
Control group: The control group will consume two capsules of maltodextrin (500 mg) each day, which is accompanied by high-intensity interval training. One of the capsules would be taken after breakfast and the other one would be taken after lunch. To ensure the supplement consumption and follow up the recreational runners' problems, the delivery of unused capsules will be requested at the end of each week. Study subjects will be asked to report any problems too. To apply the exercise protocol, the study subjects will do high-intensity interval training for five days each week (during two weeks).
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz stadiums
Full name of responsible person
Parvin Dehghan
Street address
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
dehghan.nut@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Street address
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
dehghan.nut@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
dehghan.nut@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
دانشیار
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neyshabori Street, Golghash street, Nutrition Faculty, Tabriz University Of Medical Sciences,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Fax
Email
dehghanp@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parvin Dehghan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3334 0634
Email
dehghan.nut@gmail.com

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
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
Title and more details about the data/document
Reporting the results
When the data will become available and for how long
After finishing the study and publishing the project articles
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
With permission of Project Researcher and Project Sponsor - Nutrition Research Center
From where data/document is obtainable
Dr. Parvin Dehghan, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences Email: Dehghan.nut@gmail.com Phone: +98 914 471 0299
What processes are involved for a request to access data/document
The applicant can send an application to the responsible person by email
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