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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039103
Receipt No. R000044589
Scientific Title A clinical study to evaluate the effects of chewing gum on improving efficiency of rest.
Date of disclosure of the study information 2021/03/31
Last modified on 2020/01/09

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Basic information
Public title A clinical study to evaluate the effects of chewing gum on improving efficiency of rest.
Acronym A clinical study to evaluate the effects of chewing gum on improving efficiency of rest.
Scientific Title A clinical study to evaluate the effects of chewing gum on improving efficiency of rest.
Scientific Title:Acronym A clinical study to evaluate the effects of chewing gum on improving efficiency of rest.
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effects of chewing on improving efficiency of rest at resting time after mental tasks (PC tasks)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes work performance evaluation
Key secondary outcomes autonomic nervous function evaluation, VAS, Jikaku-sho shirabe

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Chewing gum after mental tasks -> washout period ( 1 week) -> Single intake of the candy after mental tasks
Interventions/Control_2 Single intake of the candy after mental tasks -> washout period ( 1 week) -> Chewing gun after mental tasks
Interventions/Control_3
Interventions/Control_4
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
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Males and females whose age of 20 years or more and less than 65 years
2) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Key exclusion criteria 1) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects having the chronic fatigue syndrome(CFS), or subjects deemed to have severe fatigue like idiopathic chronic fatigue by the investigator
3) Subjects who has difficulty in chewing gum because of oral disease or others
4) Subjects who take regularly pharmaceuticals or quasi-drugs which having the efficacy for recovery from fatigue or nutrient replenishment in case of physical fatigue
5) Subjects who take regularly Foods with Function Claims labeled the effect of attenuating fatigue sensation
6) Subjects who have the possibility of developing allergic symptoms by the test food
7) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
8) Female subjects who are pregnant or lactating, or intending to become pregnant during the study
9) Subjects deemed unsuitable by the investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satoko
Middle name
Last name Okuyama
Organization LOTTE Co., Ltd.
Division name Central Laboratory Health Science Section
Zip code 336-8601
Address 3-3-1, Numakage, Minami-ku, Saitama
TEL 048-837-0170
Email okuyama_satoko@lotte.co.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Sugino
Organization Soiken Inc.
Division name R&D Division
Zip code 560-0082
Address Senri Life Science Center 13F,1-4-2,Shinsenri-higashimachi, Toyonaka,Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization LOTTE Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Fukuda Clinic
Address Shin-Osaka brick building 2F, 1-6-1 Miyahara, Yodogawa, Osaka, Osaka
Tel 06-6398-0203
Email fukudaclinicIRB@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 医療法人弘正会ふくだ内科クリニック(大阪府)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 31 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
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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 12 Day
Last follow-up date
2020 Year 03 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 09 Day
Last modified on
2020 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044589

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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