History
# Registration date Revision Id
2 2022-05-14, 1401/02/24 230280
1 2021-02-19, 1399/12/01 171750
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  • Protocol summary

    Determining The effect of seed powder supplementation on nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
    Determining The effect of date seed powder supplementation on nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
    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.
    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 36 recreational runners referring to Tabriz stadiums.
    مطالعه حاضر به صورت کارآزمایی بالینی دو سوکور با هدف تعیین اثر مکمل یاری پودر هسته خرما در بین 34 نفر از دوندگان تفریحی مراجعه کننده به ورزشگاه های شهر تبریز انجام خواهد یافت.
    مطالعه حاضر به صورت کارآزمایی بالینی دو سوکور با هدف تعیین اثر مکمل یاری پودر هسته خرما در بین 36 نفر از دوندگان تفریحی مراجعه کننده به ورزشگاه های شهر تبریز انجام خواهد یافت.
    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).
    36 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).
    34 نفر از دوندگان تفریحی مراجعه کننده به ورزشگاه های شهر تبریز؛ دو گروه 17 نفره ی مداخله (دریافت کننده مکمل پودر هسته خرما و فعالیت فیزیکی) و کنترل (دریافت کننده پلاسبو و فعالیت فیزیکی).
    36 نفر از دوندگان تفریحی مراجعه کننده به ورزشگاه های شهر تبریز؛ دو گروه مداخله (دریافت کننده مکمل پودر هسته خرما و فعالیت فیزیکی) و کنترل (دریافت کننده پلاسبو و فعالیت فیزیکی).
  • General information

    34
    36
    empty
    No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
    empty
    تغییراتی در پروتکل مطالعه حاضر انجام نیافته است وفقط برخی پارامترها اضافه شده اند. بر طبق مرور بر متون جامع محققین، کلیه پارامترهای اضافه شده همراه با پارامترهای ثبت شده به صورت یک طرح جامع ارایه گردیده بود. اما قبل از ثبت این طرح در مرکز کارآزمایی های بالینی بواسطه محدودیت مالی، پاره ای از پارامترهای مورد مطالعه حذف گردیده بود. اخیرا بواسطه تامین مالی طرح در قالب گرنت پژوهشی محققین برتر، محققین پارامترهای محذوف را مجددا به طرح اضافه نموده اند تا یک مطالعه جامع در این زمینه صورت پذیرد.
    The effect of seed powder in runners
    The effect of date seed powder in runners
    The effect of seed powder supplementation on nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
    The effect of date seed powder supplementation on the nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
    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).
    Participants by using software RAS, after mating based on sex and v2omax, will be divided into two groups of 18 individual intervention (receiver of date seed powder supplement and physical activity) and control (receiver of placebo and physical activity).
    افراد بعد از همسان سازی بر اساس جنس وv2omax ، به صورت تصادفی سازی طبقه ای، به دو گروه 17 نفره ی مداخله (دریافت کننده مکمل پودر هسته خرما و فعالیت فیزیکی) و کنترل (دریافت کننده پلاسبو و فعالیت فیزیکی) با استفاده از نرم افزار RAS تقسیم خواهند شد.
    افراد بعد از همسان سازی بر اساس جنس وv2omax ، به صورت تصادفی سازی طبقه ای، به دو گروه 18 نفره ی مداخله (دریافت کننده مکمل پودر هسته خرما و فعالیت فیزیکی) و کنترل (دریافت کننده پلاسبو و فعالیت فیزیکی) با استفاده از نرم افزار RAS تقسیم خواهند شد.
  • Primary outcomes

    #1
    Ferritin
    Insulin
    فریتین
    انسولین
    #2
    Serum iron
    Glucose
    آهن سرم
    گلوکز
    #3
    Insulin
    Insulin-like Growth Factor-1
    انسولین
    فاکتور رشد شبه انسولین-1
    #4
    Glucose
    Adiponectin
    گلوکز
    آدیپونکتین
    #5
    Insulin-like Growth Factor-1
    Tumor necrosis factor alpha
    فاکتور رشد شبه انسولین-1
    فاکتور نکروز تومور
    #6
    Adiponectin
    Myoglobin
    آدیپونکتین
    میوگلوبین
    #7
    PGC-1alpha expression
    Irisin
    بیان ژن PGC-1alpha
    آیریسین
    Pcr ( Polymerase chain reaction )
    Kit
    پی سی آر (واکنش زنجیره پلی مراز )
    کیت
    #8
    Tumor necrosis factor alpha
    Cortisol
    فاکتور نکروز تومور
    کورتیزول
    #9
    α1-acid glycoprotein
    Brain-Derived Neurotrophic Factor
    آلفا-۱-اسید گلیکوپروتئین
    فاکتور نورون‌زایی مشتق‌شده از مغز
    #10
    Myoglobin
    F2-isoprostanes
    میوگلوبین
    f2 ایزوپروستان ها
    #11
    Irisin
    8-Oxo-2'-deoxyguanosine
    آیریسین
    8-هيدروكسی-2-دي اوكسی گوانوزين
    #12
    Cortisol
    GSH
    کورتیزول
    گلوتاتیون
    #13
    Brain-Derived Neurotrophic Factor
    Carbonyl protein
    فاکتور نورون‌زایی مشتق‌شده از مغز
    پروتئین کربونیل
    #14
    F2-isoprostanes
    Nitric Oxide
    f2 ایزوپروستان ها
    نیتریک اکساید
    #15
    8-Oxo-2'-deoxyguanosine
    Total oxidant status
    8-هيدروكسی-2-دي اوكسی گوانوزين
    ظرفیت اکسیدانی کل
    Kit
    kit
    #16
    GSH
    glutathione peroxidase
    گلوتاتیون
    گلوتاتیون پراکسیداز
    Kit
    kit
    #17
    Carbonyl
    uric acid
    کربونیل
    اوریک اسید
    Kit
    kit
    #18
    Nitric Oxide
    empty
    نیتریک اکساید
    empty
    At baseline and two weeks after baseline
    empty
    ابتدا و دو هفته بعد از شروع مطالعه
    empty
    Kit
    empty
    کیت
    empty
    #19
    Neopterin
    empty
    نئوپترین
    empty
    At baseline and two weeks after baseline
    empty
    ابتدا و دو هفته بعد از شروع مطالعه
    empty
    Kit
    empty
    کیت
    empty
  • Secondary outcomes

    #1
    Transferrin
    CBC (Complete blood count)
    ترانسفرین
    شمارش کامل سلول های خونی
    #2
    CBC (Complete blood count)
    Sleep
    شمارش کامل سلول های خونی
    خواب
    Kit
    Questionnaire
    کیت
    پرسشنامه
    #3
    Serum iron
    empty
    آهن سرم
    empty
    At baseline and two weeks after baseline
    empty
    ابتدا و دو هفته بعد از شروع مطالعه
    empty
    Kit
    empty
    کیت
    empty
    #4
    Sleep
    empty
    خواب
    empty
    At baseline and two weeks after baseline
    empty
    ابتدا و دو هفته بعد از شروع مطالعه
    empty
    Questionnaire
    empty
    پرسشنامه
    empty
    #5
    Recovery and stress
    empty
    ریکاوری و استرس
    empty
    At baseline and two weeks after baseline
    empty
    ابتدا و دو هفته بعد از شروع مطالعه
    empty
    Questionnaire
    empty
    پرسشنامه
    empty
  • Intervention groups

    #1
    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.
    Control group: during the two weeks, the control group will receive two packets of powder containing 13 grams of wheat bran 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.
    گروه کنترل: گروه کنترل روزانه دو بسته پودر، حاوی 13 گرم پودر پلاسبو (ترکیب از مالتودکسترین، سبوس گندم و رنگ خوراکی خواهد بود که توسط شرکت داروسازی از لحاظ طعم، حجم و شکل با پودر هسته خرما مشابه سازی خواهد شد ) را به همراه انجام تمرینات تناوبي شديد کوتاه مدت دریافت خواهند نمود. یک بسته پودر قبل از تمرین و یک بسته پودر بعد از تمرین به 150 سی سی آب ولرم اضافه و بعد از اختلاط مصرف خواهد شد.
    گروه کنترل: گروه کنترل روزانه دو بسته پودر، حاوی 13 گرم پودر سبوس گندم را به همراه انجام تمرینات تناوبي شديد کوتاه مدت دریافت خواهند نمود. یک بسته پودر قبل از تمرین و یک بسته پودر بعد از تمرین به 150 سی سی آب ولرم اضافه و بعد از اختلاط مصرف خواهد شد.
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Parvin Dehghan
    Full name of responsible person - Persian: پروین دهقان
    Street address - English: Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
    Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 3334 0634
    Fax:
    Email: dehghan.nut@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Ostad Rahimi
    Full name of responsible person - Persian: علیرضا استاد رحیمی
    Street address - English: Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
    Street address - Persian: تبریز، خیابان گلگشت، دانشگاه علوم پزشکی تبریز، دانشکده تغذیه و علوم غذایی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5166614711
    Phone: +98 41 1335 2292
    Fax:
    Email: ostadrahimi@tbzmed.ac.ir
    Web page address:

Protocol summary

Study aim
Determining The effect of date 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 36 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
36 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).
Main outcome variables
Oxidative status; inflammatory status; sports performance

General information

Reason for update
No changes have been made in the protocol of the present study, and only some parameters have been added. According to the comprehensive review on registered trial, all the added parameters along with the recorded parameters were presented as a comprehensive study in this field. Unfortunately, before registering this project in the Iranian Registry of Clinical Trials due to financial constraints, some of the considered parameters were removed. Recently, due to the funding of the project via top researchers grant, researchers have re-added the deleted parameters to the project for a comprehensive study in this field.
Acronym
IRCT registration information
IRCT registration number: IRCT20150205020965N9
Registration date: 2021-02-19, 1399/12/01
Registration timing: prospective

Last update: 2022-06-18, 1401/03/28
Update count: 1
Registration date
2021-02-19, 1399/12/01
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 date seed powder supplementation on the nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
Public title
The effect of date 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: 36
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 18 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
Insulin
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

11

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

12

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

13

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

14

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

15

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

16

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

17

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

18

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

19

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

20

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

21

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

22

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

23

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

24

Description
Total oxidant status
Timepoint
At baseline and two weeks after baseline
Method of measurement
kit

25

Description
glutathione peroxidase
Timepoint
At baseline and two weeks after baseline
Method of measurement
kit

26

Description
uric acid
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
CBC (Complete blood count)
Timepoint
At baseline and two weeks after baseline
Method of measurement
Kit

4

Description
Sleep
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 wheat bran 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
Alireza Ostad Rahimi
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 1335 2292
Email
ostadrahimi@tbzmed.ac.ir
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
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