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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041985
Receipt No. R000047883
Scientific Title Effect of "healthy diet" intake on health awareness and physical
Date of disclosure of the study information 2020/10/05
Last modified on 2021/09/01

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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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