Healthy subjects
Conditions
Interventions
Test foods, Continuous intake for 4 weeks
non-intervention, Continuous 4 weeks
Sponsors
Morinaga & Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy male and female of 12 years of age at the time point of acquiring the informed consent. (2)Parents of healthy male and female who are 12 years of age at the time point of acquiring the informed consent. (3) Subjects who are not making regular visits to hospitals, taking medication, nor receiving follow-up care from any physician. (4) Subjects who are experiencing some kind of stress in their daily lives. (5) Subjects who agree to have their blood taken (approximately 10 mL) from the arm twice (before and at the end of the test) without any problems. (6) Subjects who are able to drink the test beverage once daily. (7) Subjects whose BMI is between male16.5 kg/m^2 and 27.0 kg/m^2, female 17.0 kg/m^2 and 27.0 kg/m^2 (8) Subjects whose body weight is between 35 kg and 55 kg (9) Parents must cooperate in filling out the diary and questionnaires. (10) Subjects who have received explanation and understood about this study, and who can consent to the content on the informed consent documents. (11) Subject who can answer the interview on the day of the study regarding menstruation (female participants only). (12) Children who are judged by the investigator that they have no problem participating in the study.
Exclusion criteria
Exclusion criteria: (1) Subjects who have or suspected infectious disease such as COVID-19, or who had close contact with such disease on study entry. (2) Subjects who have a history of medication, hospitalization, or surgery within a year. (3) Subjects who have a history of any kind of suggestion or guidance from a physician regarding blood glucose levels or insulin secretion. (4) Subjects who are currently on any medical treatments, or who are planning some kind of treatments during the study period. (5) Subjects who constantly take medicines, health foods and/or supplements that may affect the test results. (including vitamins, etc.) (6) Subjects whose BMI is less than male 16.5 kg/m^2, female 17.0 kg/m^2 and male and female over than 27.0 kg/m^2 (7) Weight less than 35 kg or over 55 kg (8) Subjects who feel nausea, dizziness, loss of consciousness, extreme nervousness, or fear when having blood test (including reactions such as crying or violent outbursts). (9) Subjects who cannot intake the foods containing cacao (because of preference, headache, etc.) (10) Subjects who have a habit of strenuous physical activity such as being a member of an athletic club. (11) Subjects who have allergy in medicine, foods. (Especially milk, and almonds). (12) Subjects who are unable to come to the hospital on the day of the examination. (13) Subjects who have participated in other clinical trials within 3 months prior to the date of consent, are currently participating in a clinical trial of another drug or health food, or are scheduled to participate in another clinical trial after consent to participate in this trial. (14) Subjects judged by the principal investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychological examination, blood biochemical tests, blood mineral level, anemia level, physical examination | — |
Secondary
| Measure | Time frame |
|---|---|
| observation log | — |
Countries
Japan
Contacts
Public ContactHiroyuki Inagaki
Morinaga & Co., Ltd Health Science and Research Center, R&D institute
Outcome results
None listed