UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047611 |
|---|---|
| Receipt number | R000054295 |
| 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 |
| Date of disclosure of the study information | 2022/04/28 |
| Last modified on | 2022/10/28 10:33:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
koyama.kana@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054295
