UMIN-CTR Clinical Trial

Basic information
Public title	Effect of "healthy diet" intake on health awareness and physical
Acronym	Effect of "healthy diet" intake on health awareness and physical
Scientific Title	Effect of "healthy diet" intake on health awareness and physical
Scientific Title:Acronym	Effect of "healthy diet" intake on health awareness and physical
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective this study examines changes in health consciousness and physical condition by eating a "healthy diet" that is a balanced combination of multiple nutritional components that are considered to be good for healthy at breakfast and lunch, compared with before intake .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation survey,Vital signs,Body composition,Bone density measurement,Visceral fat measurement,Ketone concentration in exhaled breath,SF-8 Japanese version,WLQ-J,OSA sleep inventory MA version,POMS2 shortened version,Dietary habits awareness survey, Blood biochemistry, Hematology,8-OHdG,Saliva s-IgA secretion concentration,Salivary s-IgA secretion rate, Intestinal flora test.
Key secondary outcomes	(Safety evaluation) Adverse events

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	4-weeks intake 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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Employees, contingent workers-temporary, temporary employees working in cooperative company 2)Subject who can be inspected on the specified inspection date 3)Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1)Subject who cannot continue to take the test food due to business trips during the intake period (subject who is known in advance that the eating rate will be less than 80%) 2)Subject who is taking medication or under medical treatment. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject who has an allergy for test food. 5)Subject who has or had a history of either medicine or alcohol dependence syndrome. 6)Subject who has or had a history of mental illness (depression) or sleep disturbance. 7)Subject who has irregular work rhythms such as working at night and shift work. 8)Subject who has extremely irregular lifestyle such as eating and sleeping. 9)Subject who has an unbalanced diet. 10)Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases (including subject who uses implantable medical electrical equipment such as pacemakers, subject who uses implantable metal medical equipment, and subject who is undergoing artificial dialysis) 11)Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 12)Subject who has blood drawn or blood component more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 13))Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 14)Subject who can't keep the daily records. 15)Subject who is judged as an inappropriate candidate according to the screening data. 16)Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	110

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	non-disclosure
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	AMC Nishi-Umeda Clinic Ethical Review Committee
Address	West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.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	2020 Year 10 Month 05 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	110
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 09 Month 17 Day
Date of IRB	2020 Year 09 Month 24 Day
Anticipated trial start date	2020 Year 10 Month 06 Day
Last follow-up date	2020 Year 12 Month 04 Day
Date of closure to data entry	2021 Year 01 Month 27 Day
Date trial data considered complete	2021 Year 01 Month 28 Day
Date analysis concluded	2021 Year 02 Month 19 Day

Other
Other related information

Management information
Registered date	2020 Year 10 Month 02 Day
Last modified on	2021 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047883

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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