UMIN-CTR Clinical Trial

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
Email	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
Email	ay.naderi@shahroodut.ac.ir

Sponsor
Institute	Shahrood University of Technology
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044659