UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062980 |
|---|---|
| Receipt number | R000072078 |
| Scientific Title | Effects of Continuous Oligosaccharide Intake on Vascular Function |
| Date of disclosure of the study information | 2026/09/18 |
| Last modified on | 2026/09/18 15:26:52 |
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Basic information
Public title
Effects of Continuous Oligosaccharide Intake on Vascular Function
Acronym
Effects of Continuous Oligosaccharide Intake on Vascular Function
Scientific Title
Effects of Continuous Oligosaccharide Intake on Vascular Function
Scientific Title:Acronym
Effects of Continuous Oligosaccharide Intake on Vascular Function
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous oligosaccharide intake for 12 weeks on vascular function by comparison with the intake of a control food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vascular endothelial function after 12 weeks of intake
Key secondary outcomes
Stool test, Blood test, Questionnaire survey
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food (1 sachet, once daily) for 12 weeks
Interventions/Control_2
Consumption of the placebo food (1 sachet, once daily) for 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. Healthy men and women aged 20 to less than 65 years at the time of obtaining consent.
2. Participants with a POMS-2 VA (Vigor-Activity) T-score of 50 or lower and an FI (Fatigue-Inertia) T-score of 50 or higher.
3. Participants whose BMI are 18.5 kg/m2 or more and less than 30 kg/m2.
4. Participants who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Participants who have severe or progressive diseases, such as cardiac-, hepatic-, kidney-, heart-, lung- and digestive- diseases, diabetes mellitus, rheumatoid arthritis, neurological disease, psychiatric disorders, endocrine disease, and other diseases.
2. Participants who exercise at least twice a week.
3. Participants who consume 40 g or more of pure alcohol per day for men or 20 g or more per day for women.
4. Participants with food allergies.
5. Participants who regularly use Foods for Specified Health Uses, foods with function claims, pharmaceuticals, or quasi-drugs that may affect energy metabolism, fatigue, vascular function, glucose metabolism, lipid metabolism, intestinal barrier or immune function, or the intestinal environment.
6. Participants who donate blood or otherwise had more than 200 mL of blood drawn within 1 month or more than 400 mL of blood drawn within 3 months prior to the date of obtaining informed consent.
7. Participants who have a smoking habit.
8. Participants who are pregnant or breastfeeding, or who intend to become pregnant during the study period.
9. Participants who participated in another study involving participants within 1 month prior to the date of informed consent, who are currently participating in another study, or who plan to participate in another study during the study period, except for studies in which participation concurrent with this study is permitted.
10. Participants who are judged unsuitable for this study by principal investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Fukuda |
Organization
Fukuda Clinic
Division name
Internal Medicine
Zip code
532-0003
Address
2F Shin-Osaka Brick Building, 1-6-1, Miyahara, Yodogawa-ku, Osaka-shi, Osaka, 532-0003, Japan
TEL
06-6398-0203
fukuda@dmclinic.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
Esaka Research Center
Zip code
564-0063
Address
B1 Esaka Soliton Building, 1-12-38, Esakacho, Suita, Osaka,, Japan
TEL
06-6338-5515
Homepage URL
Sugino@soiken.com
Sponsor or person
Institute
Meiji 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
Institutional Review Board of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa, Osaka, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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 総合医科学研究所 江坂リサーチセンター（大阪府）/ Soiken Inc., Esaka Research Center (Osaka Pref)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 18 | 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
| 2026 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 18 | Day |
Last modified on
| 2026 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072078
