UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044083
Receipt No. R000050328
Scientific Title Exploratory study : Effect of mastication of the chewy gummies on human feelings. ~ compared with gum and Ramune candy ~
Date of disclosure of the study information 2021/04/30
Last modified on 2021/04/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exploratory study : Effect of mastication of the chewy gummies on human feelings.
~ compared with gum and Ramune candy ~
Acronym Exploratory study : Effect of mastication of the chewy gummies on human feelings.
Scientific Title Exploratory study : Effect of mastication of the chewy gummies on human feelings.
~ compared with gum and Ramune candy ~
Scientific Title:Acronym Exploratory study : Effect of mastication of the chewy gummies on human feelings.
Region
Japan

Condition
Condition Healthy adult male
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effect of mastication of the chewy gummies on human feelings from the point of view of physiology and psychology and behavior as compared with gum and Ramune candy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Behavioral indicators(The result of the Hundred-Square calculations),Physiological indicators(Hemodynamics(Mean blood pressure,Heart rate,Cardiac output, Total peripheral resistance),Heart rate interval(R-R interval),The temperature of the facial skin,alpha-wave,Masseter muscle activity),Psychological index(Profile of Mood States,Visual Analog Scale,Free opinion)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 chewy gummies, 5 pieces a day + water
Interventions/Control_2 gum, 1 piece a day + energy controlled drink
Interventions/Control_3 Ramune candy,5 pieces a day + energy controlled drink
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

Not applicable
Gender Male
Key inclusion criteria 1) Students or staff from Aoyama Gakuin University Faculty of Science and Engineering or Graduate School of Science and Engineering of Aoyama Gakuin University.
2) Men not younger than 20 years old (at the time of informed consent)
3) Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria 1) Subjects who have gelatin allergy.
2) Subjects who have apple allergy.
3) Subjects who have a problem of mastication at a usual meal.
4) Subjects whose sleeping hours is less than 4 on average a week.
5) Subjects who are judged unsuitable for this study by the principal investigator.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Nozawa
Organization Aoyama Gakuin University
Division name College of Science and Engineering Department of Electrical Engineering and Electronics
Zip code 252-5258
Address 5-10-1 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa 252-5258, Japan
TEL 042-759-6262
Email akio@ee.aoyama.ac.jp

Public contact
Name of contact person
1st name Yoshio
Middle name
Last name Toyama
Organization Meiji Co., Ltd
Division name R&D division
Zip code 192-0919
Address 1-29-1 Nanakuni, Hachioji, Tokyo 192-0919, Japan
TEL 042-632-5824
Homepage URL
Email yoshio.toyama@meiji.com

Sponsor
Institute Aoyama Gakuin University
College of Science and Engineering
Department of Electrical Engineering and Electronics
Institute
Department

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

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

IRB Contact (For public release)
Organization The ethics committee of Aoyama Gakuin University
Address 5-10-1 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa 252-5258, Japan
Tel 042-759-6056
Email hito-rinri@aoyamagakuin.jp

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 青山学院大学(神奈川県)(Aoyama Gakuin University)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 30 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
2021 Year 04 Month 26 Day
Date of IRB
2021 Year 04 Month 26 Day
Anticipated trial start date
2021 Year 05 Month 07 Day
Last follow-up date
2021 Year 09 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 30 Day
Last modified on
2021 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.