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 |
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
A study to confirm the effect of immunostimulation by intake of high dietary fiber-containing foods
Japan |
Healthy adult
Not applicable | Adult |
Others
NO
To confirm the immunostimulatory effect of intaking the study food for 12 weeks
Efficacy
fecal s-IgA
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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
3
Prevention
Food |
Consecutive intake of study food A twice a day, replacing one piece a time with staple food for 12 weeks
Consecutive intake of study food B twice a day, replacing one piece a time with staple food for 12 weeks
Consecutive intake of control food twice a day, replacing one piece a time with staple food for 12 weeks
20 | years-old | <= |
64 | years-old | >= |
Male and Female
(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
(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
36
1st name | Michihiro |
Middle name | |
Last name | Sakakibara |
Nisshin Seifun Group Inc.
Basic research
356-0045
5-3-1 Tsurugaoka, Fujimino-Shi, Saitama-Ken
049-267-3928
sakakibara.michihiro@nisshin.com
1st name | Keiji |
Middle name | |
Last name | Yamamoto |
EP Mediate Co., Ltd.
Foods Department Trial Planning Section
162-0821
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
070-3023-8214
yamamoto.keiji799@eps.co.jp
Nisshin Seifun Group Inc.
Nisshin Seifun Group Inc.
Profit organization
Japan
Medical Station Clinic Research Ethics Committee
3-12-8, Takaban, Meguro-ku, Tokyo
03-6452-2712
nakagawa.akiko297@eps.co.jp
NO
メディカルステーションクリニック (Medical station clinic) (東京都)
2024 | Year | 07 | Month | 21 | Day |
Unpublished
Preinitiation
2024 | Year | 06 | Month | 27 | Day |
2024 | Year | 06 | Month | 27 | Day |
2024 | Year | 07 | Month | 22 | Day |
2024 | Year | 12 | Month | 19 | Day |
2024 | Year | 07 | Month | 03 | Day |
2024 | Year | 07 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062693
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |