UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046389 |
|---|---|
| Receipt number | R000052933 |
| Scientific Title | Evaluation of available energy of dietary fiber, two kinds of distarch phosphate by breath hydrogen test |
| Date of disclosure of the study information | 2021/12/25 |
| Last modified on | 2024/06/18 09:51:59 |
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Basic information
Public title
Evaluation of fermentability and available energy of dietary fiber by breath hydrogen test
Acronym
Evaluation of available energy of dietary fiber
Scientific Title
Evaluation of available energy of dietary fiber, two kinds of distarch phosphate by breath hydrogen test
Scientific Title:Acronym
Evaluation of available energy of dietary fiber
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the fermentability of the test substances by intestinal microbes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Concentration of breath hydrogen excretion for 14 h after ingestion of test substance
Key secondary outcomes
Abdominal symptoms for 14 h after ingestion of test substance, response of blood sugar for 3 h after ingestion of test substance
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 d
Test substance: insoluble dietary fiber A or B, 5 g suspended in warm water
Administration: 1 time/d
Interventions/Control_2
Duration: 1 d
Test substance: insoluble dietary fiber A or B, 10 g suspended in warm water
Administration: 1 time/d
Interventions/Control_3
Duration: 1 d
Test substance: insoluble dietary fiber C, 5 g suspended in warm water (negative control of fermentability)
Administration: 1 time/d
Interventions/Control_4
Duration: 1 d
Test substance: fructooligosaccharide 5 g dissolved in warm water (positive control of fermentability)
Administration: 1 time/d
Interventions/Control_5
Duration: 1 d
Test substance: glucose 30 g dissolved in warm water (positive control of digestibility)
Administration: 1 time/d
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
Healthy adults
Key exclusion criteria
1. Having or history of disease as follows, digestion or absorption disorder of carbohydrate, diabetes, abdominal diseases, respiratory disorders
2. smoker, BMI>26.5
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sadako |
| Middle name | |
| Last name | Nakamura |
Organization
Jumonji University
Division name
Department of Food Science, Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama, 352-8510, Japan
TEL
048-477-0555
nacsacj@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | Sadako |
| Middle name | |
| Last name | Nakamura |
Organization
Jumonji University
Division name
Department of Food Science, Faculty of Human Life
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza, Saitama, 352-8510, Japan
TEL
048-477-0555
Homepage URL
nacsacj@jumonji-u.ac.jp
Sponsor or person
Institute
Department of Food Science, Faculty of Human Life, Jumonji University
Institute
Department
Personal name
Funding Source
Organization
Ingredion Japan
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
Research Ethics Committee, Jumonji University
Address
2-1-28 Sugasawa, Niiza, Saitama, 352-8510, Japan
Tel
048-477-0555
k-kenkyu@jumonji-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
十文字学園女子大学、中村学園大学
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 25 | Day |
Related information
URL releasing protocol
http://masib.jp/gakkaishi/detail/D14.html
Publication of results
Published
Result
URL related to results and publications
http://masib.jp/gakkaishi/detail/D14.html
Number of participants that the trial has enrolled
21
Results
The AUCs of excretion of hydrogen gas up to 14 hours after ingestion were 0.19 for HXL-R and 0.13 for HXL-W, both of which were significantly lower than the positive control FOS. (p<0.05), and blood glucose after ingestion did not respond. As a result of the above, it was estimated that HXL-R and HXL-W have about the same amount of 0 kcal per 1 g.
Results date posted
| 2024 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 30 | Day |
Baseline Characteristics
According to the research protocol.
Participant flow
According to the research protocol.
Adverse events
None.
Outcome measures
According to the research protocol.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052933
