UMIN-CTR Clinical Trial

Basic information
Public title	A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
Acronym	A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
Scientific Title	A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
Scientific Title:Acronym	A Study for Biokinetics of a Functional Food for Healthy Adult Males and Females.
Region	Japan

Condition
Condition	No
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine biokinetics of a functional food for healthy adult males and females.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Indexes for biokinetics (AUC [0-24h], iAUC [0-24h] and Cmax:before ingestion of the test product, and 30 minutes,1,2,4,6,12, and 24 hours after ingestion of the test product.)
Key secondary outcomes	*Secondary indexes [1]Indexes for biokinetics (Tmax, AUC [0-inf], T1/2, MRT, Kel:before ingestion of the test product, and 30 minutes,1,2,4,6,12, and 24 hours after ingestion of the test product.) *Safety [1] Axillary temperature(1) [2] Blood pressure, pulsation(1) [3] Hematologic test(2) [4] Blood biochemical test(2) [5] Urine analysis(2) [6] Doctor's questions(1) [7] Side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed)(1) [8] Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed)(1) *Other index [1] Baseline characteristics(3) [2] Height(3) [3] Weight, body fat percentage, BMI(3) (1): Before ingestion of the test product, and 12 and 24 hours after ingestion of the test product. (2): Before ingestion of the test product, and 24 hours after ingestion of the test product. (3): Before ingestion of the test product.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of the test food
Interventions/Control_2
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Males and females aged 20-64 years. [2]Individuals who are healthy and have no chronic physical disease including skin disorder. [3]Individuals whose written informed consent has been obtained. [4]Individuals who can come to the designated venue for this study and be inspected. [5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5]Individuals who are a patient or have a history of or endocrine disease. [6]Individuals whose BMI is less than 18.5kg/m2 and over 30kg/m2. [7]Individuals whose systolic and diastolic blood pressures are over 140mmHg and 90mmHg, respectively. [8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [9]Individuals who experienced unpleasant feeling during blood drawing. [10]Individuals who are sensitive to the test food. [11]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [13]Individuals who are or are possibly, or are lactating. [14]Individuals who participated in other clinical studies in the past one month. [15]Individuals judged inappropriate for the study by the principal.
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Kazumoto Middle name Last name Sasaki
Organization	Medical Corporation Ichigenkai Sasaki Memorial Hospital
Division name	Chief Director
Zip code	359-1144
Address	1-7-25 Nishitokorozawa Tokorozawa-shi Saitama 359-1144, JAPAN
TEL	+81-429-23-7751
Email	soumuka@sasaki-memorial.com

Public contact
Name of contact person	1st name Tatsuo Middle name Last name Uetake
Organization	CXwellness, Inc.
Division name	Representative Director
Zip code	103-0023
Address	516 Nihonbashinagatani Bldg, 3-1-6 Nihonbashihoncho, Chuo-ku, Tokyo 103-0023, JAPAN
TEL	+81-80-4163-4418
Homepage URL
Email	uetake@cx-wellness.com

Sponsor
Institute	CXwellness, Inc.
Institute
Department

Funding Source
Organization	CloudNine Inc.
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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81528382485
Email	i.takahashi@tes-h.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

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 18 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	2021 Year 08 Month 02 Day
Date of IRB	2021 Year 08 Month 04 Day
Anticipated trial start date	2021 Year 08 Month 21 Day
Last follow-up date	2021 Year 08 Month 22 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 08 Month 18 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051608