UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049275 |
|---|---|
| Receipt number | R000056115 |
| Scientific Title | Study on the effect of fructo-oligosaccharide intake on salivary IgA secretion |
| Date of disclosure of the study information | 2022/10/21 |
| Last modified on | 2023/10/22 07:52:22 |
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Basic information
Public title
Fructo-oligosaccharide intake and salivary IgA secretion
Acronym
FOS and IgA serection
Scientific Title
Study on the effect of fructo-oligosaccharide intake on salivary IgA secretion
Scientific Title:Acronym
Salivary IgA secretion enhancement by FOS
Region
| Japan |
Condition
Condition
oral disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this study was to determine whether FOS affects salivary secretion and IgA in middle-aged and older adults who consume FOS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fructo-oligosaccharide intake increases salivary IgA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
FOS (made by Meiji Food Materia Co., Ltd.) 15 g of granule 5 g packet is taken 3 times a day for 8 weeks.
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy people over 50 years old
Key exclusion criteria
oligosaccharide and yogurt
diarrhea from oligosaccharide
Gastrointestinal disorders
Dementia
BMI below 17.5 BMI above 30.0
Men under 50kg and women under 37.5kg
Patients who took expectorants, antibiotics, or drugs that affect the intestine within one month before the test
undernourished
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
238-8580
Address
82, Inaoka, Yokosuka, Kanagawa.
TEL
+81468251500
graduate@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Keiichi |
| Middle name | |
| Last name | Tsukinoki |
Organization
Kanagawa Dental University
Division name
School of Dentistry
Zip code
2388580
Address
82, Inaoka, Yokosuka, Kanagawa.
TEL
+81468228866
Homepage URL
tsukinoki@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Meiji Food Materia 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
KDU IRB
Address
82, Inaoka, Yokosuka, Kanagawa.
Tel
046-825-1500
graduate@kdu.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 | 10 | Month | 21 | 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 | 10 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2024 | 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 | 10 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056115
