UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061271 |
|---|---|
| Receipt number | R000069604 |
| Scientific Title | Time Course of Exhaled Hydrogen Concentration After Oral Administration of Different Doses of a Silicon-Containing Supplement |
| Date of disclosure of the study information | 2026/04/15 |
| Last modified on | 2026/04/15 14:35:51 |
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Basic information
Public title
Time Course of Exhaled Hydrogen Concentration After Oral Administration of Different Doses of a Silicon-Containing Supplement
Acronym
Time Course of Exhaled Hydrogen Concentration After Oral Administration of Different Doses of a Silicon-Containing Supplement
Scientific Title
Time Course of Exhaled Hydrogen Concentration After Oral Administration of Different Doses of a Silicon-Containing Supplement
Scientific Title:Acronym
Time Course of Exhaled Hydrogen Concentration After Oral Administration of Different Doses of a Silicon-Containing Supplement
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the time course of exhaled hydrogen concentration following oral administration of different doses of a silicon-containing supplement
Basic objectives2
Others
Basic objectives -Others
Evaluation of the time course of exhaled hydrogen concentration following oral administration of a silicon-containing supplement
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Increase in exhaled hydrogen concentration from baseline during 0-8 h following oral administration of a silicon-containing supplement
Key secondary outcomes
- Cmax and AUC of the increase in exhaled hydrogen concentration from baseline during 0-8 h following oral administration of a silicon-containing supplement
- Association between gut microbiome profiles and exhaled hydrogen and methane concentrations following oral administration of a silicon-containing supplement
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Oral administration of a silicon-containing supplement according to a predefined stepwise algorithm. All participants receive 300 mg at the first administration and 100 mg at the second administration. Based on the increase in exhaled hydrogen concentration after 100 mg, participants proceed to either 50 mg or 200 mg at the third administration. Among participants who receive 50 mg, up to three participants with the highest AUC of the increase in exhaled hydrogen concentration up to 8 hours proceed to 25 mg at the fourth administration. Exhaled hydrogen concentration is measured up to 8 hours after each administration, and selected participants after 300 mg undergo additional measurements at 11 and 24 hours according to a predefined rule. A 1-week washout period is provided between administrations.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy
Key exclusion criteria
1) Individuals currently taking medicines and/or dietary supplements
2) Individuals with food allergies
3) Individuals currently participating in another clinical study, or who have participated in another clinical study within the past 3 months
4) Individuals who are pregnant, may be pregnant, or are breastfeeding
5) Individuals judged by the principal investigator or sub-investigator to be ineligible for participation in this study
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-1909
fumiko@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumiko |
| Middle name | |
| Last name | Higashikawa |
Organization
Hiroshima University Hospital
Division name
Medical Center for Translational and Clinical Research
Zip code
734-8551
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-1909
Homepage URL
healthy-life@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
SBI ALApromo 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
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-u.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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 04 | Month | 15 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069604
