UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045659 |
|---|---|
| Receipt number | 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 | 2022/12/19 16:10:13 |
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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
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
y.yamaji@mis21.co.jp
Sponsor or person
Institute
M&I Science CORP.
Institute
Department
Personal name
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
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
Completed
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
| 2022 | Year | 01 | Month | 25 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052118
