Healthy subjects
Conditions
Interventions
2-week ingestion of the test food Wash out(2 weeks) 2-week ingestion of the placebo food
2-week ingestion of the placebo food Wash out(2 weeks) 2-week ingestion of the test food
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese men and women aged 35 to 64 years old at the time of informed consent. 2)Subject with BMI from 25 less than 30 (unit: kg/m2). 3)Non-smoker 4)Subject with alcohol intake less than 30g / day. 5)Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent.
Exclusion criteria
Exclusion criteria: 1)Subject who is taking medication or under medical treatment due to serious illness. 2)Subject who has experienced chest pain or abnormal pulse at rest. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject with serious current illness or complications or history such as heart disease, liver disease, kidney disease, cardiovascular disease, blood disease, etc. 5)Subject who is treating rheumatism. 6)Subject who frequently experiences shortness of breath, dizziness, and loss of consciousness. 7)Subject who has or had a history of drug allergies, food allergies, or allergies to raw materials for test foods (soybeans, milk protein). 8)Subject who has a family member who died suddenly of unknown causes. 9)Subject who has been diagnosed as having problems with the legs and hips. 10)Subject who feels pain in their hips, knees, or body when ascending or descending stairs, etc. 11)Subject with knee surgery or disease, or those who use a cane on a daily basis. 12)Subject who has or had a history of either medicine or alcohol dependence syndrome. 13)Subject who has or had suspected of disorder with mental (such as depression) or sleep (such as insomnia and sleep apnea syndrome). 14)Subject who exercises for the purpose of maintaining or improving their physical fitness for a total of 60 minutes or more per week. 15)Subject who performs physical labor for a total of 10 hours or more per week. 16)Subject whose working hours are irregular due to night shifts, etc. 17)Subject with a weight fluctuation of more than +-5 kg within 2 months. 18)Subject who has extremely irregular lifestyle such as eating and sleeping. 19)Subject who has an unbalanced diet. 20)Subject who uses health foods, supplements, or drugs that affect fatigue reduction, fat burning, or obesity control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stable isotope excretion after test meals (during rest and exercise) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Secondary outcomes) Postprandial substrate oxidation, respiratory exchange ratio (during rest and exercise) (Safety evaluation) Vital signs, BMI, Adverse events | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed