UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study on the effects of food on oral functions
Acronym	A pilot study on the effects of food on oral functions
Scientific Title	A pilot study on the effects of food on oral functions
Scientific Title:Acronym	A pilot study on the effects of food on oral functions
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of food on oral functions
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of oral function (oral hypofunction) Assessment of dental hard tissue (anti-dental caries) Assessment of oral hygiene (saliva volume, plaque volume, oral microbiome)
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	Food
Interventions/Control_1	Ingestion of tablet containing no functional materials 3 times a day for 2 weeks
Interventions/Control_2	Ingestion of tablet containing functional materials 3 times a day for 2 weeks
Interventions/Control_3	Ingestion of pellet of gum containing no functional materials 3 times a day for 2 weeks
Interventions/Control_4	Ingestion of pellet of gum containing functional materials 3 times a day for 2 weeks
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Those regularly taking three meals 2) Those who can measure four or more teeth on the labial side and buccal side of 6 teeth of 16 (maxillary right first molar, FDI tooth code; same below), 21 (maxillary left medial tooth), 24 (maxillary left first bicuspid), 36 (mandibular left first molar), 41 (mandibular right middle incisor) and 44 (mandible right first bicuspid) Those who have FDI codes 17, 15, 11, 22, 25, 37, 35, 31, 42, 45 as substitutes for the six representative teeth 3) Those who do not have severe periodontal disease 4) Currently, those who are not treated for dental caries and periodontal disease, and with 20 or more teeth 5) Those who can not take foods or supplements written with oral hygiene, such as antimicrobial-containing tablets, Lactobacillus-containing foods and xylitol-containing gums during the test period 6) Those who can be set the oral device 7) Those who have no history of eating disorder or trismus 8) Those who do not regularly use antibiotics 9) Those who are not pregnant or lactating 10) Those who are not alcohol mass drinker or not dependent 11) Those who are not smokers 12) Those who are allowed to prohibit the use of toothpaste, mouthwash, floss and tongue brush with antibiotic and fungicide during the test period 13) Those who are allowed to use designated toothbrush and toothpaste during the test period 14) Those who received sufficient explanation about the purpose and contents of the exam, have a capacity for agreement, apply for participation voluntarily and are agree to participate in this study in writing
Key exclusion criteria	1) Those who have dental caries (C 3 or more) or severe periodontal disease at the screening test 2) Those who is taking medication for suffering from diabetes, chronic kidney disease, gastrointestinal disorder, lung disease, malignant tumor, autoimmune disease, etc. 3) Those who are undergoing treatment for serious diseases or who need to be implemented during the test period 4) Those who are or intend to currently participate in other medicines or food examination etc. 5) Those with stimulated saliva volume of less than 3.0 ml for 5 minutes 6) Those who has food allergy 7) Those wearing removable denture 8) Those who is during pregnancy, who intend to become pregnant during the study period or are breast-feeding 9) When you take antibiotics or disinfectant during the test (depending on its frequency and level) 10) When you ingest the oral health care product during the test (depending on its frequency and level) 11) Those who judged that examination is inappropriate by study responsible person 12) Those who can not be refrained from excessive intake of living bacteria-containing foods such as Lactobacillus and bifidobacteria, other fermented foods (natto, kimchi, etc.) during the test period 13) Those who are suffering from a disease requiring urgent treatment, or who have serious complications 14) Those who need dental checkup or treatment / surgery related to oral disease during the test period 15) Those who are judged unsuitable as a research subject from the respondents of the research subject background questionnaire
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroshi Takii
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of health sciences
Zip code
Address	4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL	06-6477-8425
Email	hiroshi.takii@glico.com

Public contact
Name of contact person	1st name Middle name Last name Hiroshi Takii
Organization	Ezaki Glico Co., Ltd.
Division name	Institute of health sciences
Zip code
Address	4-6-5, Utajima, Nishiyodogawa-ku, Osaka, Japan
TEL	06-6477-8425
Homepage URL
Email	hiroshi.takii@glico.com

Sponsor
Institute	Ezaki Glico Co., Ltd.
Institute
Department

Funding Source
Organization	Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	Tokyo Medical and Dental University Graduate School of Medical and Dental Sciences
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 01 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	Terminated
Date of protocol fixation	2018 Year 12 Month 17 Day
Date of IRB	2019 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 12 Month 17 Day
Last follow-up date	2019 Year 12 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 17 Day
Last modified on	2020 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040197