UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018783 |
|---|---|
| Receipt number | R000021727 |
| Scientific Title | Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine |
| Date of disclosure of the study information | 2015/08/26 |
| Last modified on | 2021/03/02 20:00:10 |
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Basic information
Public title
Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine
Acronym
Safety and efficacy evaluation of drink with a plant-derived product and carnosine
Scientific Title
Placebo-controlled double blinded parallel trial for safety and efficacy evaluation of drink containing with a plant-derived product and carnosine
Scientific Title:Acronym
Safety and efficacy evaluation of drink with a plant-derived product and carnosine
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Test to evaluate safety and efficacy of 8-week-drinking with a plant-derived product and carnosine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Number of adverse effects
Stress reaction
Key secondary outcomes
Number of adverse events
Proteins and chemicals in blood
Intestinal bacterial flora analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One drink with plant-derived product and carnosine every day for eight weeks
Interventions/Control_2
One drink without plant-derived product and carnosine every day for eight weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 20 to less than 65 years old.
2) Top 60 people detected as high stressor
3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Subjects who take continuous medical treatment.
2) Subjects who have systolic blood pressure less than 90 mmHg.
3) Subjects who are pregnant or have possibility to bocome pregnant or planning to become pregnant during the study or breast-feeding woman.
4) Subjects who donated 200 mL of blood and/or blood components within the last one month prior to the current study.
5) Male subjects who donated 400 mL of blood within the last three months prior to the current study.
6) Female subjects who donated 400 mL of blood within the last four months prior to the current study.
7) Male subjects whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
8) Female subjects whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
9) Subjects who are participating in other clinical studies, or who finished clinical study within three months.
10) Subjects who are contracting heart disease, liver disease, kidney disease and digestive disease.
11) Subjects who have contracted a disease in circulatory organs.
12) Subjects who have allergic reaction to drug medicine and food.
13) Subjects who drink alcohol or smoke a lot.
14) Subjects who have an extremely irregular diet habit or alternative work schedule or work on midnight shift.
15) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses) affecting the test results.
16) Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Norihito |
| Middle name | |
| Last name | Murayama |
Organization
Suntory Global Innovation Center Ltd.
Division name
Innovation Development Department
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284 Japan
TEL
050-3182-0588
Norihito_Murayama@suntory.co.jp
Public contact
Name of contact person
| 1st name | Jiro |
| Middle name | |
| Last name | Takano |
Organization
Suntory Global Innovation Center Ltd.
Division name
Innovation Development Department
Zip code
619-0284
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL
050-3182-0598
Homepage URL
Jiro_Takano@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
Suntory Global Innovation Center Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clini
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 26 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
60
Results
Unpublished
Results date posted
| 2021 | Year | 03 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Unpublished
Adverse events
Unpublished
Outcome measures
Unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 04 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 24 | Day |
Last modified on
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021727
