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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046577
Receipt No. R000053096
Scientific Title A study on the effect of test food intake on serotonin level - an open-label trial -
Date of disclosure of the study information 2022/01/09
Last modified on 2022/01/07

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Basic information
Public title A study on the effect of test food intake on serotonin level - an open-label trial -
Acronym A study on the effect of test food intake on serotonin level
Scientific Title A study on the effect of test food intake on serotonin level - an open-label trial -
Scientific Title:Acronym Effect of test food intake on serotonin level
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and the effect on the serotonin level of 3 weeks intake of test food containing luteolin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serotonin
Questionnaire for fecal conditions
Key secondary outcomes - C-reactive protein level (High sensitivity test)
- Leucine-rich alpha-2-glycoprotein level (LRG)
- Questionnaire for mental stress

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Take one capsule of the test food with water or warm water after breakfast once a day.
Interventions/Control_2
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. Age between 20 and 65 years old at the time of informed consent
2. Japanese males or females
3. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement.
Key exclusion criteria 1. Those who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease.
2. Those who are on diet/exercise therapy under the guidance of a doctor.
3. Those who currently have or have history of severe diseases.
4. Those who have get surgical operation on the digestive tract except appendix.
5. Those who currently have or have a history of visiting psychiatric services.
6. Those who currently have or have history of allergic dermatitis, allergic rhinitis, bronchial asthma, and chronic bronchitis.
7. Those who daily take nutritional supplements or foods that have health claims
8. Those who daily take beverage or yogurt containing lactic acid bacteria and/or Bifidobacterium.
9. Those who currently have or have a history of drug and/or food allergies.
10. Those who daily take alcohol 60 g/day or more.
11. Those who have smoked within a year.
12. Those who have plans of major change on their lifestyle (e.g. diet, sleep and exercise) during the study period.
13. Those who are planning to travel abroad during the study period.
14. Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period.
15. Those who joined other clinical trials since 1 month before receiving informed consent in this study, or those who are currently joining other clinical trials.
16. Those who are judged by the physician to be unsuitable for this study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yoji
Middle name
Last name Kato
Organization University of Hyogo
Division name School of Human Science and Environment
Zip code 670-0092
Address 1-1-12, Shinzaike-honcho, Himeji, Hyogo
TEL 079-292-9413
Email yojikato@shse.u-hyogo.ac.jp

Public contact
Name of contact person
1st name Yoshitada
Middle name
Last name Hira
Organization IMEQRD Co., Ltd
Division name Sales department
Zip code 104-0061
Address 6-2-1, Ginza, Chuo-ku, Tokyo
TEL 03-6704-5968
Homepage URL
Email y-hira@imeqrd.co.jp

Sponsor
Institute IMEQRD Co., Ltd
Institute
Department

Funding Source
Organization The Tojuro Iijima Foundation for Food Science and Technology
Organization
Division
Category of Funding Organization Non profit foundation
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
Email n-yuzawa@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
2022 Year 01 Month 09 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 Preinitiation
Date of protocol fixation
2021 Year 12 Month 22 Day
Date of IRB
Anticipated trial start date
2022 Year 01 Month 10 Day
Last follow-up date
2022 Year 02 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 07 Day
Last modified on
2022 Year 01 Month 07 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053096

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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