Healthy adult
Conditions
Interventions
Supplementation of the test food over a period of 12 weeks
Sponsors
Rohto Pharmaceutical Co.,Ltd.
MG PHARMA Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Healthy males from 18 years or older at the time of consent. (2) Person who can understand the purpose and content of this study and agree in this study.
Exclusion criteria
Exclusion criteria: (1) Subjects who are unable to ingest the study food (supplement) or who have allergies to any of its ingredients. (2) Subjects who are currently receiving medical treatment-such as outpatient care or medication-or who are judged by the study-site physician to have a significant medical history requiring exclusion. (3) Subjects who have repeatedly experienced discomfort or adverse physical reactions during past blood draws. (4) Subjects who have donated blood components or donated 200 mL or more of whole blood within one month prior to the initial examination date, or who plan to do so during the study period. (5) Subjects who are currently participating in another clinical trial, or who participated in another clinical trial within two months prior to the initial examination date. (6) Subjects who regularly use pharmaceuticals, quasi-pharmaceuticals, Kampo medicines, or health foods (including supplements, over-the-counter drugs,Foods for Specified Health Uses, and foods with functional claims) that may influence the study, or who have continuously consumed health foods likely to affect body composition or muscle function within the three months prior to providing consent. (7) Subjects with markedly irregular dietary habits or lifestyles that may substantially influence the study results. (8) Subjects who are judged unsuitable as study participants based on the results of preliminary examinations or lifestyle questionnaires. (9) Subjects who are otherwise judged unsuitable for participation in this study by the principal investigator or the study-site physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sports Performance Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Body composition measurements, Ketone body, Free fatty acids, Lactate, Creatine, Lactate dehydrogenase (LDH), Myoglobin, Cortisol,Muscle ultrasound, Functional Movement Screen (FMS) | — |
Countries
Japan
Contacts
Public ContactAkiko Kuwahara
Rohto Pharmaceutical Co.,Ltd. Internal Medicine and Functional Food Development Division
Outcome results
None listed