UMIN-CTR Clinical Trial

Basic information
Public title	A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
Acronym	A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
Scientific Title	A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
Scientific Title:Acronym	A Study of effect of a Single Ingestion of the Test Food on Autonomic Properties.
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 effect of a single ingestion of the test food on autonomic properties.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Heart rate measurements with my Beat. (Screening,Observation Period I,Observation Period II,Observation Period III,Observation Period IV.)
Key secondary outcomes	*Secondary indexes [1] Mental questionnaire (1) [2] Taste questionnaire (1) *Safety indexes [1] Blood pressure, pulsation(1) [2] Weight, body fat percentage, BMI(1) [3] Doctor's questions(1) [4] Subject's diary(2) *Other indexes [1] Baseline characteristics(3) (1):Screening,Observation Period I,Observation Period II,Observation Period III,Observation Period IV. (2):Everyday from the day before the Observation Period I to the day before the Observation Period IV. (3):Screening

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	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	[1] Oral ingestion of a placebo food (1 time/200ml). [2] Observation. [3] Washout (over 2days) [4] Oral ingestion of a test food B (1 time/200ml). [5] Observation. [6] Washout (over 2days) [7] Oral ingestion of a test food A (1 time/200ml). [8] Observation. [9] Washout (over 2days) [10] Oral ingestion of a placebo food (1 time/200ml). [11] Observation.
Interventions/Control_2	[1] Oral ingestion of a test food A (1 time/200ml). [2] Observation. [3] Washout (over 2days) [4] Oral ingestion of a placebo food (1 time/200ml). [5] Observation. [6] Washout (over 2days) [7] Oral ingestion of a test food B (1 time/200ml). [8] Observation. [9] Washout (over 2days) [10] Oral ingestion of a placebo food (1 time/200ml). [11] Observation.
Interventions/Control_3	[1] Oral ingestion of a test food B (1 time/200ml). [2] Observation. [3] Washout (over 2days) [4] Oral ingestion of a test food A (1 time/200ml). [5] Observation. [6] Washout (over 2days) [7] Oral ingestion of a placebo food (1 time/200ml). [8] Observation. [9] Washout (over 2days) [10] Oral ingestion of a placebo food (1 time/200ml). [11] Observation.
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	35 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Males and females aged 20-34 years. [2]Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3]Individuals whose BMI is less than 25.0kg/m2. [4] Individuals who are a non-smoker (no smoking in the last 1 year). [5]Individuals whose written informed consent has been obtained. [6]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals using medical products. [2] Individuals who use a drug and Chinese traditional medicine. [3]Individuals who receive a diet remedy and an exercise therapy under medical supervision. [4]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [6]Individuals who are a patient or have a history of or endocrine disease. [7]Individuals who use implantable medical devices such as a pacemaker. [8]Individuals who used a drug to treat a disease in the past 1 month. [9] Individuals who use regularly over-the-counter medicines, quasi-drugs, food for specified health uses, functional foods, health foods and other products that affect the autonomic nervous system, metabolism and sleep. [10] Individuals who will develop seasonal allergy symptoms like hay fever or have allergic rhinitis during the test period. [11]Individuals who are or may be allergic to medical products or foods. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [13]Individuals whose diet is extremely irregular. [14] Individuals whose daily life rhythm is irregular for reasons such as shift work or late nights. [15] Individuals who have experienced significant stress due to life events within 3 months prior to obtaining informed consent. [16]Individuals who are participating with other clinical trial. [17]Individuals who cannot stop drinking from the day before the test. [18]Individuals who are or are possibly pregnant, or are lactating. [19]Individuals who have severe menstrual complaints (severe) and require medication. [20]Individuals judged inappropriate for the study by the principal.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Takahiro Middle name Last name Ono
Organization	Ueno-Asagao Clinic
Division name	Head
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6240-1162
Email	info@ueno-asagao.clinc

Public contact
Name of contact person	1st name Ryoma Middle name Last name Shimizu
Organization	TES Holdings Co., Ltd.
Division name	Administrative Department of Clinical Trials
Zip code	110-0015
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL	+81-3-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization	Asahi Quality & Innovations, 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	Ueno-Asagao Clinic Ethical Review Committee
Address	6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel	+81-3-6240-1162
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	2023 Year 04 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	2022 Year 03 Month 28 Day
Date of IRB	2022 Year 03 Month 30 Day
Anticipated trial start date	2022 Year 04 Month 15 Day
Last follow-up date	2022 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 04 Month 06 Day
Last modified on	2022 Year 11 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053987