UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, parallel-group comparative study of the effect on lifestyle improvements by taking recommended foods based on the advice of the risk screening test
Acronym	Study of the effect on lifestyle improvements by taking recommended foods based on the advice of the risk screening test
Scientific Title	Randomized, parallel-group comparative study of the effect on lifestyle improvements by taking recommended foods based on the advice of the risk screening test
Scientific Title:Acronym	Study of the effect on lifestyle improvements by taking recommended foods based on the advice of the risk screening test
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate changes of My Nightingale results for adults (20 to 64 years old) when taking recommended foods based on results of My Nightingale that is a risk screening test
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	My Nightingale results
Key secondary outcomes	Physical examination (body height,weight,BMI,body fat percentage,body mass,lean body mass,muscle mass,body water mass,estimated bone mass,basal metabolic rate,visceral fat level,leg muscle score,degree of obesity) Questionnaire on lifestyle etc

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Take recommended foods based on the advice of the risk screening test My Nightingale test for 4 weeks
Interventions/Control_2	Continue usual lifestyle
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.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Healthy Japanese who are 20 years old or more and under 64 years old 3.Persons who have at least one of HDL cholesterol, LDL cholesterol, Non-HDL cholesterol, triglyceride, and fasting blood glucose below B rating according to a criteria of comprehensive health checkup from latest annual checkup or comprehensive health checkup
Key exclusion criteria	1.Persons who have chronic illness, receiving medication, have a serious disease history 2.Persons who can't taking specified ingredients (egg, dairy products, wheat, buckwheat peanut, shrimp, crab) and fish due to allergy 3.Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect the test results 4. Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam 5.Persons who were judged as inappropriate for study participants by the principal investigator 6.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kana Middle name Last name Koyama
Organization	Healthcare Systems Co., Ltd.
Division name	Clinical Research Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Email	koyama.kana@hc-sys.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Koyama
Organization	Healthcare Systems Co., Ltd.
Division name	Clinical Research Department
Zip code	105-0004
Address	Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL	03-6809-2722
Homepage URL
Email	koyama.kana@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

Funding Source
Organization	MITSUI & CO., LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Seven & i Holdings Co., Ltd.

IRB Contact (For public release)
Organization	The Ethics Committee of Healthcare Systems Co., Ltd.
Address	1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel	052-734-8885
Email	soumu@hc-sys.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 04 Month 28 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	56
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 04 Month 25 Day
Date of IRB	2022 Year 04 Month 25 Day
Anticipated trial start date	2022 Year 05 Month 09 Day
Last follow-up date	2022 Year 06 Month 27 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 28 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054295