UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039566
Receipt number R000045119
Scientific Title The effect of regular exercise and garlic consumption on some inflammatory biomarkers in sedentary individuals
Date of disclosure of the study information 2020/02/22
Last modified on 2020/02/24 01:43:09

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Basic information

Public title

Regular exercise and garlic consumption on inflammatory biomarkers in sedentary individuals

Acronym

Regular exercise and garlic consumption on inflammatory biomarkers in sedentary individuals

Scientific Title

The effect of regular exercise and garlic consumption on some inflammatory biomarkers in sedentary individuals

Scientific Title:Acronym

Regular exercise and garlic consumption on inflammatory biomarkers in sedentary individuals

Region

Asia(except Japan)


Condition

Condition

Inflammatory biomarkers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigate the effect of regular exercise and garlic consumption on some inflammatory biomarkers in sedentary individuals

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

hs-CRP
TNF-a

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Food Other

Interventions/Control_1

Exercise+garlic (ES)

Interventions/Control_2

Exercise+placebo (E)

Interventions/Control_3

Garlic (G)

Interventions/Control_4

Placebo (P)

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

30 years-old >=

Gender

Male

Key inclusion criteria

agre 20-30
sedentary male
overweight male

Key exclusion criteria

Any disease

Target sample size

44


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 Farhad
Middle name
Last name Gholami

Organization

Shahrood University of Technology

Division name

Sport science

Zip code

3619995161

Address

Semnan Province, Shahroud

TEL

02332392204

Homepage URL


Email

gholami.farhaad@gmail.com


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

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 02 Month 22 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

44

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

No longer recruiting

Date of protocol fixation

2019 Year 10 Month 05 Day

Date of IRB

2019 Year 09 Month 11 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2020 Year 01 Month 30 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 02 Month 22 Day

Last modified on

2020 Year 02 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045119


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name