UMIN-CTR Clinical Trial

Basic information
Public title	Effects of breakfast on cognitive functions
Acronym	Effects of breakfast on cognitive functions
Scientific Title	Effects of breakfast on cognitive functions
Scientific Title:Acronym	Effects of breakfast on cognitive functions
Region	Japan

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

Objectives
Narrative objectives1	This study aims at elucidating the effects of breakfast with the test food on cognitive functions, operating efficacies, and sensory scales
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1] Cognitive function test (1) [2] Work efficiency inspection (1) [3] Questionnaire survey on sensation (1) (1): Screening,Before and after ingestion of the test food. [observation period I and II]
Key secondary outcomes	*Secondary indexes [1] Blood pressure,pulsation (Screening, Before ingestion of the test food. [observation period I and II]). [2] Subject's diary (From the first day of ingestion of a test material to the last day of the test). [3] Doctor's questions (Screening, After ingestion of the test food. [observation period I and II]). *Other indexes [1] Baseline characteristics (Screening). [2] Weight,body fat percentage,BMI (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	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	[1]Oral ingestion of a test food (1 time). [2]Observation. [3]Washout (over 3days) [4]Oral ingestion of a Control food. (1 time). [5]Observation.
Interventions/Control_2	[1]Oral ingestion of a Control food (1 time). [2]Observation. [3]Washout (over 3days) [4]Oral ingestion of a test food. (1 time). [5]Observation.
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	30 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	[1] Males and females aged 30-49 years. [2] Individuals who are healthy and are not suffered from a chronic malady including skin disease. [3] Individuals whose written informed consent has been obtained. [4] 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 have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [4] Individuals who are a patient or have a history of or endocrine disease. [5] Individuals with or under treatment for memory impairment such as dementia [6] Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [7] Individuals whose BMI is over 25kg/m2. [8] Individuals who do not have the habit of eating breakfast and those who have irregular eating habits. [9] Individuals who are sensitive to the test food. [10] Individuals who are not good ingesting caffeine-containing foods such as coffee. [11] Individuals who are a smoker. [12] Individuals who habitually take the foods for specified health uses (FOSHU) or functional food (except for subjects who can stop consume them after informed consent). [13] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [14] Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15] Individuals who are or are possibly pregnant, or are lactating. [16] Individuals who participated in other clinical studies in the past 3 months. [17] Individuals who are or whose family is engaged in functional foods or cosmetics. [18] Individuals judged inappropriate for the study by the principal.
Target sample size	20

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	Nestle Japan 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	2022 Year 01 Month 13 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 12 Month 15 Day
Date of IRB	2021 Year 12 Month 16 Day
Anticipated trial start date	2022 Year 01 Month 19 Day
Last follow-up date	2022 Year 01 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 01 Month 11 Day
Last modified on	2022 Year 07 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052960