UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045754 |
|---|---|
| Receipt number | R000052239 |
| Scientific Title | Acceptability study of an appetite improvement service (tentative) using blood biomarkers as indicators |
| Date of disclosure of the study information | 2021/10/15 |
| Last modified on | 2022/04/18 10:07:26 |
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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
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
Nobuo_Fuke@kagome.co.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052239
