Healthy subjects
Conditions
Interventions
2-week ingestion of the test food A Wash out(2 weeks) 2-week ingestion of the placebo Wash out(2 weeks) 2-week ingestion of the test food B
2-week ingestion of the test food B Wash out(2 weeks)
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese males and females aged 40 years or older and under 60 years at the time of informed consent acquisition, Japanese males and females who meet the following inclusion criteria for protection of human rights and who do not conflict with the exclusion criteria and are able to comply with the management requirements during the study period. 2)Subjects with BMI of 20.7 to 27.5 in males and 18.8 to 26.0 in females. 3)Non smoker. 4)Persons who have received sufficient explanation on the purpose and content of the research, who have the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who have given written consent to participate in the research.
Exclusion criteria
Exclusion criteria: 1) Currently receiving any medication or ambulatory treatment. 2) Have a history of or complication of serious heart, liver, kidney, cardiovascular system, or blood disorders. 3) Have experienced chest pain or vein abnormalities at rest. 4) Frequent shortness of breath, light-headedness, dizziness, and loss of consciousness. 5) Have a history of drug allergy, food allergy, or allergy to raw materials (milk protein, etc.) used in test foods. 6) Have family member who died suddenly for unknown reasons. 7) Diagnosed with lumbar foot disorders. 8) Taking health foods, supplements, or drugs that may affect fatigue relief. 9) Eat extremely biased meals. 10) Extremely irregular lifestyle habits such as diet and sleep. 11) Suspected of having insomnia (insomnia, sleep apnea syndrome, etc.) 12) Present or past history of psychiatric disorder (depression, etc.) 13) Drug dependence, present illness of alcoholism, previous history. 14) Currently participating in other clinical trials or have participated in other clinical trials within the past 3 months. 15) Irregular working hours, such as those working at night. 16) Feels an effect or pain on the lower back, knee, or body during ascent or descent of stairs, etc. 17) Receiving treatment for rheumatoid arthritis. 18) Have surgery or disease of the knee or routinely use a cane. 19) Body weight fluctuates by +-10 kg or more within 1 year. 20) Wishing to become pregnant during pregnancy, lactation, or during the study period. 21) Difficulties in observing records on various questionnaires. 22) Exercising to maintain or improve physical fitness for at least 60 minutes in total per week. 23) Engaged in physical labor for 10 hours or more in total per week. 24) Scheduled to donate blood or receive vaccination or wishe to donate blood or receive vaccination during the study period. 25) Other, persons who are judged by medical doctor to be inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Substrate oxidation during exercise (maximum rate, AUC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Power output and rate of perceived exertion (RPE) at when indicated a maximum rate of substrate oxidation during exercise. Power output, RPE and respiratory exchange ratio at when indicated a ventilation threshold during exercise | — |
Countries
Japan
Contacts
Public ContactMasao Matsuoka
HUMA R&D CORP Clinical Development Division
Outcome results
None listed