UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054868 |
|---|---|
| Receipt number | R000062693 |
| Scientific Title | A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods |
| Date of disclosure of the study information | 2024/07/21 |
| Last modified on | 2024/07/03 17:27:31 |
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Basic information
Public title
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
Acronym
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
Scientific Title
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
Scientific Title:Acronym
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the immunostimulatory effect of intaking the study food for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fecal s-IgA
Key secondary outcomes
salivary s-IgA concentration, salivary s-IgA secretion rate, pDC evaluation(CD86, HLA-DR, CD40, CD80), natural killer cell activity, T cell proliferation marker(CD4, CD8), neutrophil phagocytosis, Intestinal microflora(genus-level analysis, a diversity, b diversity), fecal physical examination(fecal moisture content, fecal short-chain fatty acids), fatigue visual analogue scale, physical condition questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consecutive intake of study food A twice a day, replacing one piece a time with staple food for 12 weeks
Interventions/Control_2
Consecutive intake of study food B twice a day, replacing one piece a time with staple food for 12 weeks
Interventions/Control_3
Consecutive intake of control food twice a day, replacing one piece a time with staple food for 12 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)males and females from 20 to 64 years of age
(2)Those who are aware that they are prone to catching colds
(3)Those with no more than 5 bowel movements per week in the 2 weeks before and after the pre-examination
(4)Those who are aware of fatigue
(5)Those who are able to consume study food as a staple food twice a day
(6)Those who are able to receive and freeze the study food
(7)Those who are able to consume study food appropriately using a microwave oven
(8)Those who have fully comprehended the purpose and content of this study and provide informed consent to participate voluntarily
Key exclusion criteria
(1)Those who have a disease requiring constant medication, those with a disease under treatment, or those with a history of a serious disease
(2)Those suffering from gastrointestinal diseases, or who have a history of previous illnesses or surgeries
(3)Those with pre-existing conditions that require diet and exercise therapy under the guidance of a doctor
(4)Those who having atopic dermatitis, bronchial asthma, and chronic bronchitis
(5)Those who may be taking medicine or undergoing treatment for hay fever or allergic rhinitis
(6)Those who are taking medicines, health foods that may affect immune function or bowel movements at least 3 times a week
(7)Those who undergoing dental or oral treatment
(8)Those who results may be affected by dental or oral problems involving bleeding
(9)Those who have reported allergies to food or medicines
(10)Those who are unable to prohibit the intake of foods that may affect the outcome
(11)Those who consume foods high in fiber at least 3 times a week
(12)Those who vaccinated within 4 weeks or hope for vaccination
(13)Heavy drinkers of alcohol
(14)Heavy excessive smokers
(15)Those who are planning to travel overseas
(16)Those who are becoming pregnant and lactating or intend to become pregnant
(17)Night and day shift worker
(18)Those whose cohabitants plan to participate in the study
(19)Those who plan to change their lifestyle, eating habits, or living environment
(20)Those that dietary habits are irregular
(21)Those who had one meal or less per day at least once a week
(22)Those who are on a carbohydrate restriction or diet
(23)Those who have collected 200 mL of blood within 1 month or more than 400 mL within 3 months
(24)Those who have participated in other clinical studies within one month or plan to participate
(25)Those who pre-test values are significantly out of the reference range
(26)Those who are judged as unsuitable for the study by the investigator
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Sakakibara |
Organization
Nisshin Seifun Group Inc.
Division name
Basic research
Zip code
356-0045
Address
5-3-1 Tsurugaoka, Fujimino-Shi, Saitama-Ken
TEL
049-267-3928
sakakibara.michihiro@nisshin.com
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Yamamoto |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
070-3023-8214
Homepage URL
yamamoto.keiji799@eps.co.jp
Sponsor or person
Institute
Nisshin Seifun Group Inc.
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 21 | 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 | 06 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 19 | 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 | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062693
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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