UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054040 |
|---|---|
| Receipt number | R000061698 |
| Scientific Title | Study on metabolism and bioavailability of newly developed saccharide material, 1-deoxymannose, in humans |
| Date of disclosure of the study information | 2024/04/02 |
| Last modified on | 2024/04/02 18:34:43 |
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Basic information
Public title
Study on bioavailability of newly developed saccharide material, 1-deoxymannose, in humans
Acronym
Bioavailability of 1-deoxymannose in humans
Scientific Title
Study on metabolism and bioavailability of newly developed saccharide material, 1-deoxymannose, in humans
Scientific Title:Acronym
Study on metabolism and bioavailability of 1-deoxymannose in humans
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the bioavailability of the test sample in humans and to accumulate the data necessary to evaluate its relative available energy.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of exhaled hydrogen gas
Key secondary outcomes
Urinary excretion amount of 1-deoxymannose
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Duration: 1 day
Test materials: 1-deoxymannose
Dose: 5 g
Administration: Take once a day at once with water
Interventions/Control_2
Duration: 1 day
Test materials: 1-deoxymannose
Dose: 2.5 g
Administration: Take once a day at once with water
Interventions/Control_3
Duration: 1 day
Test materials: 1-deoxymannose
Dose: 1 g
Administration: Take once a day at once with water
Interventions/Control_4
Duration: 1 day
Test materials: fructooligosaccharide
Dose: 5 g
Administration: Take once a day at once with water
Interventions/Control_5
Duration: 1 day
Test materials: mannose
Dose: 5 g
Administration: Take once a day at once with water
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese adults
Key exclusion criteria
The exclusion criteria are diabetes mellitus, abnormal glucose metabolism, respiratory disease, chronic gastrointestinal disease (inflammatory bowel disease, irritable bowel syndrome, functional dyspepsia, etc.), abdominal surgery, history of abnormal bowel movements, blood disorders, food allergies, or BMI of 25.0 or higher. Smokers, excessive alcohol drinkers, and pregnant or lactating women will be excluded. Also exclusion criteria are those who regularly consume non-digestible and absorbable carbohydrates, including dietary fiber, and those who routinely consume pharmaceuticals, foods for specified health uses, functional foods, or health foods.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Faculty Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
tanabek@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Faculty Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
Homepage URL
tanabek@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jumonji University
Name of secondary funder(s)
SUNUS Co., Ltd.
IRB Contact (For public release)
Organization
Ethical Review Committee for Research Involving Human Subjects in Nakamura Gakuen University
Address
5-7-1 Befu, Jonan-ku, Fukuoka
Tel
092-851-2598
tanabek@nakamura-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
中村学園大学（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 02 | 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 | 02 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061698
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
