UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057998 |
|---|---|
| Receipt number | R000066303 |
| Scientific Title | Effect of intake of grain derived dietary fiber on the intestinal environment |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2025/11/26 11:11:55 |
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Basic information
Public title
Effect of intake of grain derived dietary fiber on the intestinal environment
Acronym
Effect of intake of grain derived dietary fiber on the intestinal environment
Scientific Title
Effect of intake of grain derived dietary fiber on the intestinal environment
Scientific Title:Acronym
Effect of intake of grain derived dietary fiber on the intestinal environment
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratory evaluate the effects of continuous intake of flaxseed- or okara-containing foods for 4 weeks on the intestinal environment adults aged 18 to under 65.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal microbiota
Key secondary outcomes
Short-chain fatty acids in feces
Questionnaire on defecation status
Physical examination (height, weight, BMI) (self-reported)
Dietary records (may be examined as needed)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 15 g of flaxseed-containing foods daily for 4 weeks.
Interventions/Control_2
Intake 15 g of okara-containing foods daily for 4 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate in the research
2.Japanese (who have Japanese nationality) aged 18 to 64 at the time of obtaining consent
3.Persons who have defecation frequency of 3-5 times a week at screening
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who regularly take a large amount of dietary fiber
4.Persons who regularly take medicines, health foods (food for specified health use, food with functional claims, food with nutrient function claims), supplements etc. that may affect the intestinal environment
5.Persons who have chronic constipation or chronic diarrhea
6.Persons who have a BMI below 18.5 kg/m2 or 30.0 kg/m2 and above
7.Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research.
8.Persons who are judged to be ineligible by the supervising doctor or the principal investigator
9.Persons who are lactating, pregnant, or planning or wishing to become pregnant during the research period
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Aida |
Organization
NIPPN CORPORATION
Division name
Innovation Center, Central Research Laboratory
Zip code
243-0041
Address
5-1-3, Midorigaoka, Atsugi, Kanagawa, JAPAN
TEL
046-222-6963
kaida@nippn.co.jp
Public contact
Name of contact person
| 1st name | Suzuka |
| Middle name | |
| Last name | Oyama |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
oyama.suzuka@hc-sys.jp
Sponsor or person
Institute
NIPPN CORPORATION
Institute
Department
Personal name
Funding Source
Organization
NIPPN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Healthcare Systems Co., Ltd.
Name of secondary funder(s)
National Institutes of Biomedical Innovation, Health and Nutrition
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2025 | Year | 05 | Month | 28 | 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
24
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066303
