UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043066 |
|---|---|
| Receipt number | R000049170 |
| Scientific Title | An exploratory study of new features of test foods. - A placebo controlled, randomized, double blind, cross-over study - |
| Date of disclosure of the study information | 2021/02/06 |
| Last modified on | 2021/07/21 15:10:34 |
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Basic information
Public title
An exploratory study of new features of test foods.
- A placebo controlled, randomized, double blind, cross-over study -
Acronym
An exploratory study of new features of test foods.
Scientific Title
An exploratory study of new features of test foods.
- A placebo controlled, randomized, double blind, cross-over study -
Scientific Title:Acronym
An exploratory study of new features of test foods.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of promoting the excretion of fat, sugar, salt and cholesterol in the meal by ingesting test foods.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal examination:
Cholesterol, Crude fat, Sodium, Carbohydrates
Key secondary outcomes
Fecal examination:
Bile acid, Water content, Weight, Dietary fiber
Urinalysis: Sodium, Creatinine
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo drink (a single time intake) -> 4days washout -> Test drink (a single time intake).
Interventions/Control_2
Test drink (a single time intake) -> 4days washout -> Placebo drink (a single time intake).
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male
Key inclusion criteria
(1)Healthy men aged 20-29 years old when informed consent.
(2)Subjects who can take 3 prescribed meals and designated meals a day.
(3)Subjects who defecate 1 or more a day.
(4)Subjects who can stay at the accommodation from Friday night to Sunday noon and do not need to go out from the accommodation or the examination site during the test.
(5)Subjects who are judged not suffering from a disease by the investigator.
(6)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1)Subjects who has determined to be inappropriate as a subject by the investigator by a blood test performed on a screening test.
(2)Subjects who have chronic disease and regularly use drugs and/or medicines and have serious complications.
(3)Subjects who regularly use medicines related to intestinal regulation.
(4)Subjects who has food allergy.
(5)Subjects who take health foods (including Food for Specified Health Uses or Foods with Function Claims) and/or supplements on a daily basis.
(6)Subjects who have digestive disorders that affect digestion and absorption and/or have a history of digestive surgery, and/or have disorders of the digestive tract such as stricture.
(7)Subjects who couldn't take the prescribed meal to be carried out within the prescribed time in the screening test.
(8)Subjects who had problems with gastrointestinal symptoms such as diarrhea and abdominal pain after taking the prescribed meal in the screening test.
(9)Subjects who did not defecate pigmented stool within 26 hours after taking the prescribed meal and pigment capsule in the screening test.
(10)Subjects who may do a lot of sweating work or exercise during the test period.
(11)Subjects who smoke.
(12)Subjects who usually have a tendency to develop diarrhea or constipation.
(13)Subjects who has a medical history or current medical history of drug dependence and/or alcohol dependence.
(14)Subjects who are participating in other studies that using foods, pharmaceuticals, and cosmetics now, or who have been participated or are willing to participate in other studies within a month from the date of informed consent.
(15)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Nissin Foods Holdings 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
医療法人財団健康睡眠会 日本橋循環器科クリニック
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 06 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049170
| Research Plan | |
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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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| Registered date | File name |
