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A study on the effect of test food intake on serotonin level - an open-label trial -

A study on the effect of test food intake on serotonin level - an open-label trial - - Effect of test food intake on serotonin level

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046577
Enrollment
10
Registered
2022-01-09
Start date
2022-01-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Take one capsule of the test food with water or warm water after breakfast once a day.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Serotonin Questionnaire for fecal conditions

Secondary

MeasureTime frame
- C-reactive protein level (High sensitivity test) - Leucine-rich alpha-2-glycoprotein level (LRG) - Questionnaire for mental stress

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026