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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
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 | 2020/10/27 |
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 |
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Condition | ||
Condition | Healthy subjects | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 110 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
ochitani@huma-rd.co.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 | No longer recruiting | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |