The effect of aerobic physical activity alone and in combination with hemp seed powder consumption on biophysical, metabolic and neurological parameters in sedentary young men
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Determining the effect of aerobic physical activity alone with hemp seed powder consumption on biophysical, metabolic and neurological factors in sedentary young men
Design
Randomized, double-blind clinical trial with four parallel groups
Settings and conduct
The study will be performed in the ergometrics laboratory of the Faculty of Health and Nutrition and in clinics affiliated to Tabriz University of Medical Sciences and the duration of the supplementary course will be 8 weeks. hemp seed powder and placebo capsules will be coded by the person in charge of preparation and the main researchers and patients will be blind to the type of supplement taken in each group.
Participants/Inclusion and exclusion criteria
Use any medication or diet and exercise supplement for at least 2 months before the start of the study, respiratory disease, cardiovascular disease and hypertension, diabetes, thyroid disease, neurological disease, musculoskeletal disease, autoimmune disease, skeletal and joint problems
Intervention groups
The intervention group will consume 2 capsules of hemp powder daily and will also work out on the treadmill three times a week. The control group will also take a capsule containing cornstarch (placebo) which will be similar to the supplement.
Main outcome variables
Biophysical factors (balance, strength, mental function), Brain drieved neuronal factor (BDNF), Neuropeptide Y (NPY), Blood insulin and insulin resistance, Fasting blood sugar, Lipid profile, Renal function indicators (total iron-binding capacity, creatinine, urea, uric acid), Serum electrolytes (total iron-binding capacity, magnesium, iron, calcium, phosphorus), high-sensitivity C-reactive protein, Liver function (ALT, AST, direct bilirubin, ALP, albumin, total bilirubin, total protein), Lactate dehydrogenase activity, Creatine kinase activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140907019082N10
Registration date:2021-02-20, 1399/12/02
Registration timing:prospective
Last update:2021-11-17, 1400/08/26
Update count:2
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Mahdieh Abbasalizad Farhangi
Name of organization / entity
Department of Community Nutrition School of Nutrition
Country
Iran (Islamic Republic of)
Phone
+98 413357580
Email address
abbasalizadm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-10, 1399/12/20
Expected recruitment end date
2021-12-07, 1400/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aerobic physical activity alone and in combination with hemp seed powder consumption on biophysical, metabolic and neurological parameters in sedentary young men
Public title
The effect of aerobic physical activity and cannabis powder consumption in sedentary young men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male
age 18-40
low active
Inclination to participate in the study
Exclusion criteria:
Use any medication or diet and exercise supplements for at least 2 months before the start of the study
Respiratory disease
Cardiovascular disease and hypertension
Diabetes
Thyroid disease
Nervous disease
Skeletal muscle disease
Autoimmune disease
Skeletal and joint problems
Age
From 18 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all the blocks is the same and we will have 4 blocks in this four-group experiment. The randomization tool is also used from the site www.sealedenvelope.com, which is a site for generating random sequences, in addition to simple randomization, is able to generate random sequences by blocking method. For concealment, we use allocation concealment, which is the method used to execute a random sequence on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are placed in the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main researchers (including students, supervisors, and advisors) as well as participants will be unaware of the type of supplement (hemp seed or placebo) received by each group. The person in charge of preparing the supplement packs (who is completely unrelated to the study) will be asked to assign a three-digit code to each of the two powders (hemp seed and placebo) and, until the end of the study and data analysis, Keep the codes with you.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Third Floor, Central Building No. 2, Tabriz University of Medical Sciences, Golghast St.
Liver function (ALT, AST, direct bilirubin, ALP, albumin, total bilirubin, total protein)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELIZA
11
Description
Lactate dehydrogenase activity
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELIZA
12
Description
Creatine kinase activity
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELIZA
Secondary outcomes
1
Description
Anthropometric indices
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Seca Scale, stadiometer and strip meter
2
Description
Body composition
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
With the body composition analyzer
Intervention groups
1
Description
Intervention group: People in the physical activity group with supplements, take 2 capsules of hemp seed powder a day, one before lunch and one the night before bed, and also work out on a treadmill three times a week.
Category
Treatment - Drugs
2
Description
Intervention group: Instead of hemp seed, people in the physical activity group will take a capsule containing cornstarch, which is similar to a supplement, before lunch and at night before going to bed, and will also work out on a treadmill three times a week.
Category
Treatment - Other
3
Description
Intervention group: . People in the supplement group take 2 capsules of hemp seed powder a day, one before lunch and one the night before bed.
Category
Treatment - Drugs
4
Description
Control group: People in the control group will also take capsules containing cornstarch, which will be similar to the supplement, before lunch and at night before bed.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Nutrition, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Street address
Tabriz - Golgasht St. - Attar Neyshabouri St. - Faculty of Nutrition and Food Sciences
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۱۱
Phone
+98 41 3335 7580
Email
nutritionfaculty@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Golgasht St. / Tabriz University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
research-vice@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
Ali Mohammad Rezaei
Position
Master student in sports nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه و علوم غذایی
City
tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۱۱
Phone
+98 41 3335 7580
Email
alimrezaei4@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mahdieh Abbasalizad Farhangi
Position
Associate Professor of Nutrition Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Fax
+98 41 3334 0634
Email
Abbasalizad_m@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mohammad Rezaei
Position
Master student in sports nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
خیابان گلگشت، خیابان عطار نیشابوری، دانشکده تغذیه و علوم غذایی
City
Tabriz
Province
East Azarbaijan
Postal code
۵۱۶۶۶۱۴۷۱۱
Phone
+98 41 3335 7580
Email
Alimrezaei4@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available