UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications	https://www.meiji.co.jp/corporate/pressrelease/2021/1201_01/index.html
Number of participants that the trial has enrolled	30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	None
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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 07 Month 12 Day
Date of closure to data entry	2021 Year 07 Month 12 Day
Date trial data considered complete	2021 Year 09 Month 07 Day
Date analysis concluded	2021 Year 10 Month 07 Day

Other
Other related information

Management information
Registered date	2021 Year 04 Month 30 Day
Last modified on	2021 Year 12 Month 08 Day

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