Adult male and female
Conditions
Interventions
Continuous intake of test food (1 bottle a day) for 48 weeks
No intake
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Male and female aged 75 years or older (2) Subjects who have been certified as needing assistance level 1, assistance level 2, nursing care level 1, or nursing care level 2 (3) Subjects with a BMI of less than 25 kg/m^2 (4) Subjects who can obtain written consent to participate in the study from the person himself/herself or a legal representative regarding the purpose and content of the study. When obtaining consent from a legal representative, the purpose and content of the study must be explained to the subject so that he/she can understand it, and an effort must be made to obtain consent from the subject himself/herself (informed assent)
Exclusion criteria
Exclusion criteria: (1) Subjects suffering from a disease that may be life-threatening during the study period (2) Subjects who have difficulty orally ingesting the study food (3) Subjects who cannot ingest the study food due to dietary restrictions for the disease they are being treated for (4) Subjects who may develop allergies related to the study (Subjects with allergies to milk or soybeans) (5) Subjects who may experience abdominal symptoms when ingesting the study food or yogurt (6) Subjects who regularly consume foods containing the relevant ingredients and cannot stop during the study period (7) Subjects who have participated or plan to participate in other studies within one month from the date of consent acquisition or during the study (8) Subjects who are judged to be unsuitable as subjects based on their responses to the lifestyle questionnaire (9) Subjects who are judged to be unsuitable as subjects based on clinical test values and measurements (10) Subjects who are judged to be unsuitable as subjects by the responsible physician for other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI, muscle mass, appendicular skeletal muscle mass, appendicular skeletal muscle mass index, grip strength, blood markers such as nutritional indexes, dietary survey, GDS15, CNAQ-J, PSQI-J, daily life record (fever, hospitalization) | — |
Countries
Japan
Contacts
Public ContactMariko Kondo
EP Mediate Co., Ltd. Development department, Trial planning section
Outcome results
None listed