UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000045206 |
|---|---|
| Receipt number | R000051642 |
| Scientific Title | A study to investigate responders to food ingredients - A randomized, double-blind, placebo-controlled, crossover study - |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2021/12/21 21:11:09 |
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Basic information
Public title
A study to investigate responders to food ingredients
- A randomized, double-blind, placebo-controlled, crossover study -
Acronym
A study to investigate responders to food ingredients
Scientific Title
A study to investigate responders to food ingredients
- A randomized, double-blind, placebo-controlled, crossover study -
Scientific Title:Acronym
A study to investigate responders to food ingredients
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The study aims to investigate psychological effects of food ingredient intakes to explore responders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological evaluation
Heart rate data
Key secondary outcomes
Genetic polymorphism
Interoceptive sense
Values and Personality survey
Background survey (menstrual cycle, levels of menstrual pain, and beverage intake preferences)
Beverages drinking patterns and behaviors
Flavor evaluation
BMI
Stress
Lifestyle (obesity)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will intake placebo (200 mL) within 15 minutes
Interventions/Control_2
Participants will intake test liquid 1(200 mL) within 15 minutes
Interventions/Control_3
Participants will intake test liquid 2(200 mL) within 15 minutes
Interventions/Control_4
Participants will intake test liquid 3(200 mL) within 15 minutes
Interventions/Control_5
Participants will intake test liquid 4(200 mL) within 15 minutes
Interventions/Control_6
Participants will intake test liquid 5(200 mL) within 15 minutes
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) Healthy men and women, aged 20-59 years, at the time of an informed consent
2) Subjects who have given written consent to participate in research conducted by DeNA Life Science using samples and information obtained through MYCODE, the genetic testing service
3) Subjects that are given sufficient explanation about the purpose and contents of the study, and those agreed and volunteered to participate with good understanding of the study
4) Subjects who are able to come to the designated study date and participate in the study
5) Subjects with BMI less than 30.0
6) Non-smokers (those that have not smoked in the past year)
Key exclusion criteria
1) Subjects who are receiving continuous pharmaceutical treatment
2) Subjects with previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive system)
3) Subjects who have hay fever (during the study period) and/or allergic rhinitis (seasonal or year-round)
4) Subjects who are receiving nutrition therapy or physical therapy under doctor's supervision
5) Subjects who are regularly taking OTC medicines, quasi-drugs, and/or any food/functional food claiming an effect on autonomic nervous system, metabolism, and sleep (except for those who will be able to quit taking these after agreeing to participate until the end of the study)
6) Subjects who drink excessively (drinking 60g of pure alcohol or more, for more than five days a week)
7) Subjects with extremely irregular life cycles (e.g., midnight shift work) and/or those with extremely irregular dining habits
8) Subjects with current or past (less than 1 month) experience of participating in other clinical studies at the time of informed consent, or those planning to participate in other clinical studies during or after (within four weeks) the study period
9) Subjects who might be under extreme stress due to large life events (e.g., changing jobs, moving, divorce) that has happened three months prior to agreeing to participate in the study
10) Subjects with difficulty not taking alcohol the day before their scheduled date of the study
11) Subjects with allergy to certain medicine and/or food
12) Subjects with defects in heart rate measurement (subjects with cardiac pacemakers or thick chest hair)
13) Subjects who cannot drink alcohol
14) Subjects who cannot drink energy drinks
15) Female subjects who are pregnant and/or lactating
16) Subjects with a severe symptom of PMS (premenstrual syndrome)
17) Any other subjects who are judged by the principal investigator responsible for the study to be inappropriate to participate in the study
Target sample size
102
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yoneyama |
Organization
DeNA Life Science, Inc
Division name
Member of the Board
Zip code
150-0002
Address
2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL
0120-08-4946
IRB_dis@dena.com
Public contact
Name of contact person
| 1st name | Ryuichiro |
| Middle name | |
| Last name | Kurata |
Organization
DeNA Life Science, Inc
Division name
MYCODE service Dept
Zip code
150-0002
Address
2-24-12, Shibuya, Shibuya-ku, Tokyo
TEL
0120-08-4946
Homepage URL
IRB_dis@dena.com
Sponsor or person
Institute
DeNA Life Science, Inc
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
The ethical committee of DeNA Life Science, Inc
Address
2-24-12, Shibuya, Shibuya-ku, Tokyo
Tel
0120-08-4946
IRB_dis@dena.com
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
| 2022 | Year | 10 | Month | 01 | 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 | 07 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 28 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2021 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051642
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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