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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045659
Receipt No. R000052118
Scientific Title Overdose safety study of test foods in healthy adult males and females
Date of disclosure of the study information 2021/10/04
Last modified on 2021/10/04

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Basic information
Public title Overdose safety study of test foods in healthy adult males and females
Acronym Overdose safety study of test foods in healthy adult males and females
Scientific Title Overdose safety study of test foods in healthy adult males and females
Scientific Title:Acronym Overdose safety study of test foods in healthy adult males and females
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the safety of the test food by having healthy males and females between 20 and 65 years of age consume the test food continuously for 4 weeks.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Vital signs, physical measurements, blood biochemistry, hematology, urinalysis, adverse events
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 4-week intake of the test food
Interventions/Control_2 4-week intake of the placebo
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.Japanese males and females who are between 20 and 65 years of age at the time of written informed consent.
2.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria 1.Those who are currently receiving medication or hospital treatment for some serious disease
2. those who are currently undergoing exercise or diet therapy under the supervision of a physician
3. those who may develop allergies to the test food
4. those who are currently or have ever been dependent on drugs or alcohol
5. those who are hospitalized for mental disorders (depression, etc.) or sleep disorders, or have a history of mental disorders in the past
6. those whose life rhythm is irregular due to night work, shift work, etc.
7. Those with extremely irregular eating, sleeping, or other habits.
8. those who eat extremely unbalanced meals
9. those who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), renal diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases
10. those who are using health foods, supplements, or medicines that affect neutral fat
11.Those who have participated in other clinical trials (research) within 3 months prior to the date of consent, or those who have plans to participate in other clinical trials (research) during the study period.
12. those who have collected more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or those who have donated blood components.
13.The patient is currently pregnant or breastfeeding. Those who are currently pregnant or breastfeeding, or who may become pregnant or breastfeeding during the study period.
14.Those who are not able to download and use the designated application.
15. those who have difficulty in complying with the recording on the various questionnaires
16.Those who are judged to be unsuitable as subjects based on clinical laboratory values and measurements at the time of SCR.
17.Those who are judged to be unsuitable as subjects by the investigator.
Target sample size 32

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Yamatsu
Organization Pharma Foods International Co., Ltd.
Division name Development Department 1
Zip code 615-8245
Address 1-49, Goryo Ohara, Kyoto Shi Nishikyo Ku, Kyoto Fu, 615-8245, Japan
TEL 075-394-8600
Email a-yamatsu@pharmafoods.co.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Yamaji
Organization M&I Science CORP.
Division name Public Relations Department
Zip code 531-0071
Address Nakatsugurando Bld.10F, 1-17-26, Nakatsu, Osaka Shi Kita Ku, Osaka Fu, 531-0071, Japan
TEL 06-7878-6780
Homepage URL
Email y.yamaji@mis21.co.jp

Sponsor
Institute M&I Science CORP.
Institute
Department

Funding Source
Organization HUMA HOLDINGS Co.,Ltd.
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 NISHI-UMEDA Clinic for Asian Medical Collaboration Clinical Research Institutional Review Board
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
2021 Year 10 Month 04 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 Preinitiation
Date of protocol fixation
2021 Year 09 Month 10 Day
Date of IRB
2021 Year 09 Month 30 Day
Anticipated trial start date
2021 Year 10 Month 05 Day
Last follow-up date
2021 Year 12 Month 14 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 04 Day
Last modified on
2021 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052118

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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