Healthy subjects
Conditions
Interventions
4-week intake of the test food
4-week intake of the placebo
Sponsors
M&I Science CORP.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Japanese males and females who are between 20 and 65 years of age at the time of written informed consent. 2.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1.Those who are currently receiving medication or hospital treatment for some serious disease 2. those who are currently undergoing exercise or diet therapy under the supervision of a physician 3. those who may develop allergies to the test food 4. those who are currently or have ever been dependent on drugs or alcohol 5. those who are hospitalized for mental disorders (depression, etc.) or sleep disorders, or have a history of mental disorders in the past 6. those whose life rhythm is irregular due to night work, shift work, etc. 7. Those with extremely irregular eating, sleeping, or other habits. 8. those who eat extremely unbalanced meals 9. those who have or have had serious diseases such as brain diseases, malignant tumors, immune diseases, diabetes, liver diseases (hepatitis), renal diseases, heart diseases, etc., thyroid diseases, adrenal diseases, and other metabolic diseases 10. those who are using health foods, supplements, or medicines that affect neutral fat 11.Those who have participated in other clinical trials (research) within 3 months prior to the date of consent, or those who have plans to participate in other clinical trials (research) during the study period. 12. those who have collected more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or those who have donated blood components. 13.The patient is currently pregnant or breastfeeding. Those who are currently pregnant or breastfeeding, or who may become pregnant or breastfeeding during the study period. 14.Those who are not able to download and use the designated application. 15. those who have difficulty in complying with the recording on the various questionnaires 16.Those who are judged to be unsuitable as subjects based on clinical laboratory values and measurements at the time of SCR. 17.Those who are judged to be unsuitable as subjects by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vital signs, physical measurements, blood biochemistry, hematology, urinalysis, adverse events | — |
Countries
Japan
Contacts
Public ContactYukihiro Yamaji
M&I Science CORP. Public Relations Department
Outcome results
None listed