Determining The effect of seed powder supplementation on nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
Design
The present study will be conducted as a double-blind clinical trial with the aim of determining the effect of date seed powder supplementation indices among 34 recreational runners referring to Tabriz stadiums.
Settings and conduct
The present study will be conducted as a double-blind trial with the aim of determining the effect of date seed powder supplementation in runners referring to Tabriz stadiums.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 18 to 35 years old; doing two exercises 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 date seed powder in the last 3 months, not doing high-intensity interval training during the last 3 months and willingness to cooperate during the study. Exclusion criteria: musculoskeletal injury; smoking; alcohol consumption; hormone therapy; long-term use of drugs; dietary supplements; intake of antihypertensives, diuretics and antidiabetics; pregnancy; lactation; diabetes; anemia (Hb <13g / dl); cardiovascular disease; infectious diseases; malignancy and cognitive disorders during the study.
Intervention groups
34 recreational runners of Tabriz stadiums; two groups of intervention (receiver of date seed powder supplement and physical activity) and control (receiver of placebo and physical activity).
The effect of seed powder supplementation on nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
Public title
The effect of seed powder in runners
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 35 years old
Doing two exercises 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 date seed powder in the last 3 months
Not doing high-intensity interval training during the last 3 months
Willingness to cooperate
Exclusion criteria:
Musculoskeletal injury
Smoking, alcohol consumption
Hormone therapy
Long-term use of drugs
Use of dietary supplements
Pregnancy, lactation
Diabetes, anemia (Hb <13g / dl), cardiovascular disease , infectious diseases, malignancy and cognitive disorders
Intake of antihypertensives, diuretics and antidiabetics
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Participants by using software RAS, after mating based on sex and v2omax, will be divided into two groups of 17 individual intervention (receiver of date seed powder supplement and physical activity) and control (receiver of placebo and physical activity).
Blinding (investigator's opinion)
Double blinded
Blinding description
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.1399.1011
Health conditions studied
1
Description of health condition studied
Runners
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit
2
Description
Malondialdehyde
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
High-sensitivity C-reactive Protein
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit
5
Description
Interleukin 10
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit
6
Description
Interleukin 6
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 ( Polymerase chain reaction )
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 (Complete blood count)
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: during the two weeks, the intervention group will receive two packets of powder containing 13 grams of date seed powder with high-intensity interval training. One packet of pre-workout powder and one packet of post-workout powder will be added to 150 cc of lukewarm water and consumed after mixing.
Category
Prevention
2
Description
Control group: during the two weeks, the control group will receive two packets of powder containing 13 grams of placebo powder (The combination of maltodextrin, wheat bran and food coloring will be simulated by the pharmaceutical company in terms of taste, volume and shape with date seed powder.) with high-intensity interval training. One packet of pre-workout powder and one packet of post-workout powder will be added to 150 cc of lukewarm water and consumed after mixing.
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
Tabriz University Of Medical Sciences, Nutrition Faculty, Attar Neyshabori Street, Golghash street.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
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
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 3335 7580
Email
dehghan.nut@gmail.com
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