Protocol summary
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Study aim
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Determining The effect of date seed powder supplementation on nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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).
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Main outcome variables
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Oxidative status; inflammatory status; sports performance
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2021-02-19, 1399/12/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-02-20, 1399/12/02
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Expected recruitment end date
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2021-03-06, 1399/12/16
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of date seed powder supplementation on the nutritional, oxidative, inflammatory and anti-inflammatory status and sport performance in runners
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Public title
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The effect of date seed powder in runners
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 35 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
36
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-25, 1399/11/06
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Ethics committee reference number
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IR.TBZMED.REC.1399.1011
Health conditions studied
1
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Description of health condition studied
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Runners
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Total antioxidant capacity
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
2
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Description
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Malondialdehyde
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
3
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Description
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Superoxide dismutase
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
4
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Description
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High-sensitivity C-reactive Protein
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
5
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Description
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Interleukin 10
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
6
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Description
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Interleukin 6
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
7
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Description
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Creatine Kinase
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
8
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Description
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Lactate dehydrogenase
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
9
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Description
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Sport performance
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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questionnaire
10
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Description
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Insulin
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
11
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Description
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Glucose
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
12
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Description
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Insulin-like Growth Factor-1
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
13
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Description
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Adiponectin
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
14
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Description
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Tumor necrosis factor alpha
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
15
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Description
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Myoglobin
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
16
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Description
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Irisin
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
17
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Description
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Cortisol
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
18
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Description
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Brain-Derived Neurotrophic Factor
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
19
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Description
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F2-isoprostanes
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
20
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Description
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8-Oxo-2'-deoxyguanosine
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
21
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Description
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GSH
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
22
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Description
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Carbonyl protein
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
23
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Description
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Nitric Oxide
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
24
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Description
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Total oxidant status
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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kit
25
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Description
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glutathione peroxidase
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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kit
26
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Description
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uric acid
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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kit
Secondary outcomes
1
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Description
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Nutritional status (energy and macronutrients intake)
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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3-days food intake record
2
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Description
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Body composition
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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(BIA, BC-418 MA)
3
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Description
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CBC (Complete blood count)
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Kit
4
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Description
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Sleep
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Timepoint
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At baseline and two weeks after baseline
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Reporting the results
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When the data will become available and for how long
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After finishing the study and publishing the project articles
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To whom data/document is available
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Academic researchers
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Under which criteria data/document could be used
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With permission of Project Researcher and Project Sponsor - Nutrition Research Center
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From where data/document is obtainable
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Dr. Parvin Dehghan, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences Email: Dehghan.nut@gmail.com Phone: +98 914 471 0299
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What processes are involved for a request to access data/document
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The applicant can send an application to the responsible person by email
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Comments
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