UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052182 |
|---|---|
| Receipt number | R000059555 |
| Scientific Title | Confirmatory Trial on Changes in Subjective Satisfaction and Biomarker Responses to a Test Beverage - A Randomized Single-blind Crossover Comparative Trial - |
| Date of disclosure of the study information | 2023/09/13 |
| Last modified on | 2024/05/27 18:16:47 |
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Basic information
Public title
Confirmatory Trial on Changes in Subjective Satisfaction and Biomarker Responses to a Test Beverage - A Randomized Single-blind Crossover Comparative Trial -
Acronym
Confirmatory Trial on Changes in Subjective Satisfaction and Biomarker Responses to a Test Beverage
Scientific Title
Confirmatory Trial on Changes in Subjective Satisfaction and Biomarker Responses to a Test Beverage - A Randomized Single-blind Crossover Comparative Trial -
Scientific Title:Acronym
Confirmatory Trial on Changes in Subjective Satisfaction and Biomarker Responses to a 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 confirm the correlation between subjective satisfaction and biomarker responses to test beverages.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Hedonic VAS
- Homeostatic VAS
- Sensory VAS
- Salivary markers
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single intake of 500g of Test Food A.
Interventions/Control_2
A single intake of 500g of Test Food B.
Interventions/Control_3
A single intake of 500g of Test Food C.
Interventions/Control_4
A single intake of 500g of Test Food D.
Interventions/Control_5
A single intake of 500g of Test Food E.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age: Over 20 and under 60
2. Gender: Japanese males and females
3. Those who can enter electronic medical questionnaires via smartphone or iPad
4. Those who voluntarily participated after receiving a full explanation of the purpose and content of the study and gave written consent to participate
Key exclusion criteria
1. Those currently receiving treatment for any disease, or undergoing treatment with medication or Chinese medicine (intermittent use acceptable)
2. Those who experienced significant changes in lifestyle habits (diet, sleep, exercise habits, etc.) or environment (moving, unemployment, divorce, death of a spouse or relative, etc.) within a month before obtaining consent
3. Those planning to make significant changes to their lifestyle habits (diet, sleep, exercise habits, etc.) during the study period
4. Those with abnormalities in smell or taste
5. Those with diseases related to saliva secretion, such as dry mouth or Sjogren's syndrome
6. Those with drug addiction, or had in the past
7. Those with severe liver, kidney, heart, respiratory, endocrine, or metabolic diseases (diabetes), either current or past
8. Those who have undergone gastrointestinal surgery (excluding appendicitis)
9. Those with current or past drug allergies or food allergies
10. Those currently taking over-the-counter medicines and quasi-drugs, health food, or supplements for health maintenance or recovery, and cannot stop taking them during the study period
11. Those with irregular lifestyles (shift work, night work, etc.)
12. Heavy drinkers (pure alcohol intake: 40g/day or more)
13. Those currently pregnant or breastfeeding, or wishing to become pregnant during the study period
14. Those who participated or are participating in other clinical studies within a month before obtaining consent, or planning to participate during the study period
15. Those deemed unsuitable for participation in this study by the research physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Higashi Koganei Sakura Clinic
Division name
Director
Zip code
184-0011
Address
4-37-26,Higashicho,Koganei-shi,Tokyo,Japan
TEL
042-382-3888
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
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
0367045968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality and 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,Shinjyuku,Tokyo
Tel
0367045968
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
| 2023 | Year | 09 | Month | 13 | 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
| 2023 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059555
