An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators -A randomized, double-blind,placebo-controlled, parallel-group comparative study-

An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators -A randomized, double-blind,placebo-controlled, parallel-group comparative study- - An exploratory study to determine whether continuous intake of test foods has an effect on mood indicators.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000060298

Enrollment

Registered

2026-01-09

Start date

2026-01-13

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

None listed

Interventions

Intake of test food A for 4 weeks Intake of test food B for 4 weeks Intake of control food for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Japanese males and females aged of 20-64 years. 2)Subjects who defecate 2-5 times from the screening test per week. 3)Subjects who can drink coffee every day 4)Subjects who can visit the study site on the scheduled date 5)Subjects who recognize the object and contents of the study and submit the written informed consent.

Exclusion criteria

Exclusion criteria: 1)Subjects who regularly use laxatives or antibiotics 2)Subjects with a history or current history of serious diseases such as heart, liver, kidney, cancer, or tuberculosis (including cases of complications of other diseases) 3)Subjects who are currently receiving medication for illness or injury at the time of screening (excluding those prescribed medication for transient symptoms such as colds or hay fever) or who are scheduled to undergo surgery during the study period 4)Subjects who regularly use medicines, quasi-drugs, health foods and supplements (such as capsules) affecting the study. 5)Subjects who are shift workers or graveyard shift workers. 6)Subjects with extremely irregular daily habits and eating habits. 7)Subjects who will experience major changes in their living environment (such as moving, relocation, etc.) during the study period 8)Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) or smokers. 9)Subjects who have ever felt unwell due to blood sampling. 10)Subjects who may have allergic symptoms to the test food 11)Subjects who donated 200 mL or more of blood within 1 month from the screening test or who are scheduled to do so during the study period 12)Subjects already participating in other clinical trials or who plan to participate in other clinical trials between the time of obtaining consent for this study and the final examination 13)Pregnant, breastfeeding, or likely to become pregnant during the study period 14)Subjects who are ineligible due to physician's judgment.

Design outcomes

Primary

Measure	Time frame
POMS2 Japanese version	—

Secondary

Measure	Time frame
Fatigue VAS,State-Trait Anxiety Inventory-Form JYZ (STAI),Oguri-Shirakawa-Azumi Sleep Inventory MA version	—

Countries

Japan

Contacts

Public ContactToyotada Ashino

Trans Genic Inc. Clinical Research Department

toyotada.ashino@transgenic.co.jp0123-34-0412

Outcome results