UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053367 |
|---|---|
| Receipt number | R000060905 |
| Scientific Title | Effects of simultaneous intake of water-soluble liquid konjac and indigestible dextrin on gut microbiota composition in young women: an open-label, cross-over, before-after comparison, dose-dependent study |
| Date of disclosure of the study information | 2024/01/16 |
| Last modified on | 2024/07/16 11:37:56 |
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Basic information
Public title
Effects of simultaneous intake of water-soluble liquid konjac and indigestible dextrin on gut microbiota composition in young women: an open-label, cross-over, before-after comparison, dose-dependent study
Acronym
Effects of simultaneous intake of water-soluble liquid konjac and indigestible dextrin on gut microbiota composition in young women: an open-label, cross-over, before-after comparison, dose-dependent study
Scientific Title
Effects of simultaneous intake of water-soluble liquid konjac and indigestible dextrin on gut microbiota composition in young women: an open-label, cross-over, before-after comparison, dose-dependent study
Scientific Title:Acronym
Effects of simultaneous intake of water-soluble liquid konjac and indigestible dextrin on gut microbiota composition in young women: an open-label, cross-over, before-after comparison, dose-dependent study
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in human gut microbiota composition with continuous intake of test substances.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in human gut microbiota with continuous intake of test substances.
Key secondary outcomes
1. Subjective defecation status.
2. Body weight.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 4 weeks.
Test substance: water-soluble liquid konjac and indigestible dextrin-containing food (120 g/1 bag).
Administration: 1 time/day.
Interventions/Control_2
Duration: 4 weeks.
Test substance: water-soluble liquid konjac and indigestible dextrin-containing food (120 g/1 bag).
Administration: 2 time/day.
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
1. Food allergy (especially konjac).
2. Took antibiotics within 3 weeks of the start of this study.
3. Regularly use laxatives.
4. Diseases of the large intestine, prone to diarrhea and other gastrointestinal diseases.
5. Having or history of chronic diseases as follows, malignant tumor, heart failure, or myocardial infarction.
6. Having or history of chronic diseases as follows, cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases.
7. Pregnant, lactating, or planning to become pregnant during this trial.
8. Participate in other clinical studies or participated in the last 28 days or plan to participate in other clinical studies.
9. Smoker.
10. BMI>30.0 or BMI<17.0.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Misaki |
| Middle name | |
| Last name | Kurawaka |
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
m-krwk@jumonji-u.ac.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Kurawaka |
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
m-krwk@jumonji-u.ac.jp
Sponsor or person
Institute
Jumonji University
Institute
Department
Personal name
Funding Source
Organization
Konnyakuya-Honpo 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
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（埼玉県）、一般財団法人辨野腸内フローラ研究所（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 16 | 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
27
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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 11 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060905
