Healthy Adults
Conditions
Interventions
Ingest 2 tablets of the test food (polyamine-containing capsules) each after breakfast, lunch and dinner (total 6 tablets: 1,800 mg) daily for 12 weeks.
Ingest 2 tablets of the placebo food each after
Sponsors
Healthcare Systems Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Persons who received sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document 2.Japanese men who are 50 years old or more and under 65 years old
Exclusion criteria
Exclusion criteria: 1.Persons who have any chronic illnesses with medication and who have any serious disease histories 2.Persons who have any allergies to the ingredients used in the test food (especially persons who have allergies to wheat) 3.Persons who regularly take large amounts of polyamine-containing supplements 4.Persons who regularly take soy foods 5.Persons who regularly use medicines or foods with health claims (foods for specified health use, foods with functional claims and foods with nutritional claims) etc., that may affect skeletal muscle mass. 6.Persons who have participated in other tests within the past one month before the start of test, or those who intend to participate in another exam after consenting to the exam 7.Persons who were judged as inappropriate for study participant by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal muscle mass | — |
Secondary
| Measure | Time frame |
|---|---|
| Urine polyamine Urine deoxypyridinoline Muscle mass (Right arm, Left arm,Truncus, Right leg, Left leg) Grip strength Back muscle strength Leg strength Blood pressure (Systolic and Diastolic) Questionnaire regarding cognitive function | — |
Countries
Japan
Contacts
Public ContactKosei Nishikawa
Healthcare Systems Co., Ltd. Clinical Research Department
Outcome results
None listed