UMIN-CTR Clinical Trial

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
Email	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
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049170