UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054729 |
|---|---|
| Receipt number | R000062516 |
| Scientific Title | Continuous intake study of test beverage - A randomized, double-blind, placebo-controlled study - |
| Date of disclosure of the study information | 2025/06/23 |
| Last modified on | 2024/10/16 10:54:28 |
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Basic information
Public title
Continuous intake study of test beverage - A randomized, double-blind, placebo-controlled study -
Acronym
Continuous intake study of test beverage
Scientific Title
Continuous intake study of test beverage - A randomized, double-blind, placebo-controlled study -
Scientific Title:Acronym
A randomized, double-blind, placebo-controlled, continuous intake study of test beverage
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate effects of 4weeks intake of test beverage in healthy males and females 20 years old or older, and under 70 years old.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence rate of side effects
Key secondary outcomes
Body weight, BMI, blood pressure, pulse, hematological examination, biochemical blood test, urinalysis, incidence rate of adverse events
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
intake of test beverage, two 500mL bottles per day, for 4 weeks
Interventions/Control_2
intake of placebo beverage, two 500mL bottles per day, for 4 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: 20 to less than 70 years
2. Japanese males and females
3. Capable of data entry on electronic diary via a smartphone or PC
4. Individuals who have received adequate explanation regarding the trial, can comprehend its contents, and have produced written consent
Key exclusion criteria
1.Currently undergoing medical, pharmacological, or herbal treatment (except for on-demand medicines)
2.Currently have serious hepatic, renal, cardiac, respiratory, endocrine, or metabolic disease
3.Have a risk of allergies to the test beverage
4.Regularly taking commercially available pharmaceuticals, quasi drugs, food for specified health use (FOSHU), health food, or supplements, and unable to stop taking during the test period
5.Have a history of or current food / drug allergy
6.Habitual heavy drinkers (benchmark: daily pure alcohol consumption exceeding 40g)
7.Heavy smokers (benchmark: 21 cigarettes per day or more)
8.Those planning major lifestyle changes (diet, sleep, exercise habits, etc.) during the test period
9.Those planning travel abroad during the test period
10.Currently pregnant or breastfeeding, or hoping to get pregnant during the test period
11.Participants in other clinical trials, within one month before consent to participate in this study, or planning to participate in other clinical trials during the test period of this study
12.Individuals deemed unsuitable for the trial by the principal investigator or co-principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Yamada |
Organization
LSI Sapporo Clinic
Division name
Director
Zip code
065-0013
Address
Kita13johigashi 1-2-50, Higashi-ku, Sapporo, Hokkaido
TEL
011-711-1331
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1, Ginza, Chuo-ku, Tokyo
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
ASAHI QUALITY & INNOVATIONS, 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku-ku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 23 | 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
| 2024 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 21 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062516
