UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057877 |
|---|---|
| Receipt number | R000065614 |
| Scientific Title | Long-term intake safety verification study of oligosaccharide-containing foods |
| Date of disclosure of the study information | 2025/05/15 |
| Last modified on | 2025/04/08 17:11:36 |
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Basic information
Public title
Long-term intake safety verification study of oligosaccharide-containing foods
Acronym
Long-term intake safety verification study of oligosaccharide-containing foods
Scientific Title
Long-term intake safety verification study of oligosaccharide-containing foods
Scientific Title:Acronym
Long-term intake safety verification study of oligosaccharide-containing foods
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the safety of the test food after 12 consecutive weeks of consumption.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Changes and Variations in Physical Examinations
2) Clinical Laboratory Changes and Variations
3) Doctor's questions
4) Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed)
5) Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed)
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (1 packet in a day; 12 weeks).
Interventions/Control_2
Oral intake of the control food (1 packet in a day; 12 weeks).
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women between 20 and 65 years of age at the time of obtaining consent to participate in the study.
2) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing.
3) Individuals who can come to the designated venue for this study and be inspected.
4) Individuals judged appropriate for the study by the principal.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals suffering from or undergoing treatment for renal disease, liver disease, cardiac, respiratory, endocrine, or other metabolic diseases, psychiatric disorders, or sleep disorders, as well as individuals with a history of serious illness.
3) Individuals with gastrointestinal diseases affecting digestion and absorption and a history of gastrointestinal surgery (except appendicitis).
4) Individuals who are regular drug users and have a history of taking medication for the purpose of treating a disease in the past month (excluding abrupt medication history such as headache, menstrual cramps, common cold, etc.).
5) Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
6) Individuals who experienced unpleasant feeling during blood drawing.
7) Individuals with diarrhea or excessive constipation on a daily basis.
8) Individuals who have difficulty swallowing.
9) Individuals with drug or food allergies.
10) Individuals who are aware of lactose intolerance.
11) Individuals who have a habit of consuming Food for Specified Health Use, Food with Functional Claims, Food with Nutrient Function Claims or Health Foods.
12) Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day).
13) Shift workers or night workers
14) Individuals with possible changes of life style during the test period (e.g., work at night, travel for long periods of time, etc.).
15) Individuals who are pregnant, lactating or may become pregnant during the study period
16) Individuals who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial.
17) Individuals judged inappropriate for the study by the principal.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Aiko |
| Middle name | |
| Last name | Nakano |
Organization
Meiji Co., Ltd.
Division name
Clinical Study Management Group Health Science Research Unit
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
042-632-5847
aiko.nakano@meiji.com
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.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
うえのあさがおクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 15 | 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
| 2025 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 22 | 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 | 05 | Month | 15 | Day |
Last modified on
| 2025 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065614
