UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name

Organization

The Tojuro Iijima Foundation for Food Science and Technology

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

01

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2021

Year

12

Month

22

Day

Date of IRB

2021

Year

12

Month

21

Day

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 related information

Registered date

2022

Year

01

Month

07

Day

Last modified on

2022

Year

03

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053096