UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056680 |
|---|---|
| Receipt number | R000064777 |
| Scientific Title | Clinical trial on swallowing study of tablet supplements in adult men and women. |
| Date of disclosure of the study information | 2025/02/28 |
| Last modified on | 2025/01/10 13:18:59 |
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Basic information
Public title
Clinical trial on swallowing study of tablet supplements in adult men and women. open crossover study.
Acronym
Clinical trial on swallowing study of tablet supplements in adult men and women.
Scientific Title
Clinical trial on swallowing study of tablet supplements in adult men and women.
Scientific Title:Acronym
Clinical trial on swallowing study of tablet supplements in adult men and women.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the acceptability (tolerance rate) of taking supplements of different shapes.
Basic objectives2
Others
Basic objectives -Others
The purpose is not to assess the efficacy of the formulation, but to assess the ease of swallowing the formulation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tolerability of each tablet when actually ingested (tolerance rate).
Key secondary outcomes
Number of grains expected to be swallowed at one time when each tablet is visually observed.
Questionnaire
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take tablets of different shapes.
Interventions/Control_2
Take tablets of different shapes.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese men and women
2) Aged from 30 to 69 years old
3) Subjects who have been taking supplements in tablet form for at least two days a week for at least one month prior to obtaining consent.
Key exclusion criteria
1) Subjects with a history of swallowing affecting swallowing function.
2) Subjects who intend to become pregnant or lactating
11) Subjects who are judged as unsuitable by the research director, research manager, or trustee for other reasons.
Target sample size
182
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Functional Food Research Institute, FANCL Research Institute
Zip code
244-0806
Address
12-13 Kamishinano, Yokohama Totsuka-ku, Kanagawa
TEL
045-820-3425
sateramoto@fancl.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mori |
Organization
Macromill, Inc.
Division name
Clinical Research Unit, Life Science Division
Zip code
108-0075
Address
Shinagawa East One Tower 11F, 2-16-1 Konan, Minato-ku, Tokyo Japan
TEL
03-6716-0700
Homepage URL
yuk_mori@macromill.com
Sponsor or person
Institute
Macromill, Inc.
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
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
FANCL Corporation Ethics Committee
Address
12-13 Kamishinano, Yokohama Totsuka-ku, Kanagawa
Tel
045-820-3657
akihide_nisihara@fancl.co.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
株式会社マクロミル 社内実査会場
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 28 | 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
| 2024 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 02 | 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
| 2025 | Year | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064777
