UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048878 |
|---|---|
| Receipt number | R000055698 |
| Scientific Title | Improving effect of dairy ingredients on dry feeling : Randomized, double-blind, crossover study. |
| Date of disclosure of the study information | 2022/09/07 |
| Last modified on | 2023/03/30 14:27:37 |
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Basic information
Public title
Improving effect of dairy ingredients on dry feeling : Randomized, double-blind, crossover study.
Acronym
Improving effect of dairy ingredients on dry feeling.
Scientific Title
Improving effect of dairy ingredients on dry feeling : Randomized, double-blind, crossover study.
Scientific Title:Acronym
Improving effect of dairy ingredients on dry feeling.
Region
| Japan |
Condition
Condition
None (Healthy subjects)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a dairy ingredient on dry feeling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dry feeling
Key secondary outcomes
Saliva-related indexes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single intake of dairy ingredient.
Interventions/Control_2
A single intake of placebo.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects between 18 to 65 years old.
Key exclusion criteria
1) Subjects whose salivary flow rate are less than 0.1mL/min.
2) Subjects who have diseases of tooth, mouth, pharynx, larynx, esophagus and respiratory apparatus.
3) Subjects who cannot stop taking functional foods or using oral care products, that influence oral environment.
4) Mouth breather.
5) Subjects who put a burden on their mouth, pharynx, larynx, esophagus and respiratory apparatus.
6) Smoker.
7) Extremely heavy drinkers (more than 60g/day of alcohol).
8) Subjects whose wake-up time and bedtime are irregular.
9) Subjects who have serious disease in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, metabolic system, or have chronic disease etc. Or those who have serious medical history of these.
10) Subjects having a serious food allergy such as milk allergy, or drug allergy. Or those who have serious medical history of these.
11) Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study.
12) Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background etc.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Tomita |
Organization
Tamagawa University
Division name
Department of Advanced Food Sciences, College of Agriculture
Zip code
194-8610
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, Japan
TEL
042-739-8267
shinichi@agr.tamagawa.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Tomita |
Organization
Tamagawa University
Division name
Department of Advanced Food Sciences, College of Agriculture
Zip code
194-8610
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, Japan
TEL
042-739-8267
Homepage URL
shinichi@agr.tamagawa.ac.jp
Sponsor or person
Institute
Tamagawa University
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry 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
Ethics committee of Tamagawa University
Address
6-1-1 Tamagawa Gakuen, Machida, Tokyo, Japan
Tel
042-739-8666
t.instit@adm.tamagawa.ac.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 07 | 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
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055698
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
