UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039156 |
|---|---|
| Receipt number | R000044659 |
| Scientific Title | Effect of High intensity interval training and honey consumption on some inflammatory indices in sedentary subjects |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2020/01/14 20:22:48 |
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Basic information
Public title
Effect of High intensity interval training and honey consumption on some inflammatory indices in sedentary subjects
Acronym
High intensity interval training and some inflammatory indices
Scientific Title
Effect of High intensity interval training and honey consumption on some inflammatory indices in sedentary subjects
Scientific Title:Acronym
High intensity interval training
Region
| Asia(except Japan) |
Condition
Condition
Sedentary subjects
Classification by specialty
| Rehabilitation medicine | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of high intensity interval training and honey consumption on IL-6, IL-12 and TNF-a levels in sedentary individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IL-6
IL-12
TNF-a
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Participants of this group underwent a supervised high intensity interval training program over 8 weeks. In addition, received the equal volume of water solution with 5 gr sucrose.
Interventions/Control_2
Participants of this group underwent a supervised high intensity interval training program over 8 weeks. In addition, received 5 cc/kg body mass of 13% honey dissolved in plain water within 30-60 min before each exercise session
Interventions/Control_3
Received 5 cc/kg body mass of 13% honey dissolved in plain water within 30-60 min before each exercise session
Interventions/Control_4
Received the equal volume of water solution with 5 gr sucrose
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy state
Inactive life-style
Key exclusion criteria
History of smoking
Heart diseases
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | Farhad |
| Middle name | |
| Last name | Gholami |
Organization
Shahrood University of Technology
Division name
Sport science
Zip code
3619995161
Address
Semnan Province, Shahroud
TEL
02332392204
gholami.farhaad@gmail.com
Public contact
Name of contact person
| 1st name | Aynollah |
| Middle name | |
| Last name | Naderi |
Organization
Shahrood University of Technology
Division name
Sport science
Zip code
3619995161
Address
Semnan Province, Shahroud
TEL
02332392204
Homepage URL
ay.naderi@shahroodut.ac.ir
Sponsor or person
Institute
Shahrood University of Technology
Institute
Department
Personal name
Funding Source
Organization
Shahrood University of Technology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shahrood University of Technology
Address
Semnan Province, Shahroud
Tel
02332392204
gholami.farhaad@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 14 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044659
