UMIN-CTR Clinical Trial

Basic information
Public title	Acceptability study of an appetite improvement service (tentative) using blood biomarkers as indicators
Acronym	Acceptability study of an appetite improvement service (tentative) using blood biomarkers as indicators
Scientific Title	Acceptability study of an appetite improvement service (tentative) using blood biomarkers as indicators
Scientific Title:Acronym	Acceptability study of an appetite improvement service (tentative) using blood biomarkers as indicators
Region	Japan

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

Objectives
Narrative objectives1	To investigate the acceptability of the appetite improvement service (tentative).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Results of questionnaire on acceptability, frequency of use of home delivered meals
Key secondary outcomes	blood biomarkers concentration,body weight,appetite-related score,frequency of consumption of certain vegetables

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	Behavior,custom
Interventions/Control_1	Biomarker levels in the blood of each subject will be assessed on a level 1-7,and based on the results,dietary guidance will be given to add specific vegetables to the diet.
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	60 years-old >
Gender	Female
Key inclusion criteria	1) Person who is a member of Personal Training Studio UNDEUX Ginza or Shinbashi. 2) Person who is a woman between the ages of 20 and 60. 3) Person who is using a course designed to prevent rebounding. 4) Person who have not checked any of the exclusion criteria in the web screening. 5) Person who has no other health concerns for participation in the study.
Key exclusion criteria	1) Person whose health may be harmed by blood collection. (Specifically, those who feel sick during blood collection, those who are allergic to antiseptics (alcohol) or adhesive bandages, those who have skin diseases on their fingers, those who are taking blood-thinning medication (warfarin, etc.), those who are on hemodialysis, and those who have undergone mastectomy. 2) Those who may be allergic to certain vegetables recommended for intake in the dietary guidance. 3) Others who are judged inappropriate by the principal investigator or principal investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Ushida
Organization	KAGOME CO., LTD.
Division name	Nature & Wellness Research Department, Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	(+81)287-36-2935
Email	Yusuke_Ushida@kagome.co.jp

Public contact
Name of contact person	1st name Nobuo Middle name Last name Fuke
Organization	KAGOME CO., LTD.
Division name	Nature & Wellness Research Department, Innovation Division
Zip code	329-2762
Address	17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL	(+81)287-36-2935
Homepage URL
Email	Nobuo_Fuke@kagome.co.jp

Sponsor
Institute	KAGOME CO., LTD.
Institute
Department

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

Other related organizations
Co-sponsor	TRIATH inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethics committees of KAGOME CO., LTD.
Address	3-21-1, F tower, Hamacho, Nihonbashi, Tyuo-ku, Tokyo, Japan
Tel	03-5623-8501
Email	Takuji_Hayakawa@kagome.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2021-R11
Org. issuing International ID_1	the ethics committees of KAGOME CO., LTD.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	UNDEUX 銀座スタジオ、新橋スタジオ (東京都)

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 15 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 10 Month 05 Day
Date of IRB	2021 Year 10 Month 14 Day
Anticipated trial start date	2021 Year 10 Month 16 Day
Last follow-up date	2022 Year 01 Month 31 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 10 Month 15 Day
Last modified on	2022 Year 04 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052239