UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051239 |
|---|---|
| Receipt number | R000058432 |
| Scientific Title | Effects of simultaneous continuous intake of non-digestible oligosaccharides and monoglucosyl hesperidin on the bioavailability of monoglucosyl hesperidin in humans. |
| Date of disclosure of the study information | 2023/06/02 |
| Last modified on | 2024/04/16 09:43:59 |
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Basic information
Public title
Effect of simultaneous continuous intake of non-digestible oligosaccharides and glycosylated hesperidin on the absorption of glycosylated hesperidin
Acronym
Effect of simultaneous intake of dietary fiber and glycosylated hesperidin on absorption of glycosylated hesperidin
Scientific Title
Effects of simultaneous continuous intake of non-digestible oligosaccharides and monoglucosyl hesperidin on the bioavailability of monoglucosyl hesperidin in humans.
Scientific Title:Acronym
Effect of simultaneous ingestion of non-digestible oligosaccharides and monoglucosyl hesperidin on the bioavailability of monoglucosyl hesperidin
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether the simultaneous ingestion of the test substances increases the absorption of the test substance.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood dynamics of monoglucosyl hesperidin before and after ingestion of test substances
Key secondary outcomes
Analysis for intestinal microbes in feces
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
After a single intake of monoglucosyl hesperidin (1 g) prior to continued consumption of the test substance, the subjects were given a continuous intake of non-digestible oligosaccharides (3 g fructooligosaccharides) and monoglucosyl hesperidin (340 mg) for 14 days. The subjects will then be tested again after 14 days.
Interventions/Control_2
After a single intake of monoglucosyl hesperidin (1 g) prior to continued consumption of the test substance, the subjects were given a continuous intake of monoglucosyl hesperidin (340 mg) for 14 days. The subjects will then be tested again after 14 days.
Interventions/Control_3
After a single intake of monoglucosyl hesperidin (1 g) prior to continued consumption of the test substance, the subjects were given a continuous intake of non-digestible oligosaccharides (3 g fructooligosaccharides) for 14 days. The subjects will then be tested again after 14 days.
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy Japanese adult females
Key exclusion criteria
1. History of diabetes, abnormal glucose metabolism, respiratory disease, chronic gastrointestinal disease, or food allergy
2. BMI greater than 25.0
3. Smokers or those with excessive drinking habits
4. Pregnant or lactating mothers
5. Persons who routinely consume pharmaceuticals, foods for specified health uses, functional foods, or health foods that are thought to have the potential to affect test results
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutrional 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 of 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
Nakamura Gakuen University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 02 | Day |
Last modified on
| 2024 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058432
| 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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