Healthy male/female adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Healthy male/female subjects ranging in age from 20 to 64, at informed consent. (2) Subjects who do not have a habit of exercises. (3) Subjects ranging in BMI from 23.0 to less than 30.0 kg/m2. (4) Subjects who can give the consent to partake in this trial after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Subjects taking steadily (not less than 3 times a week) in the following affecting foods; health-specific, functional, health foods (related to blood pressure, blood stream, exercise fatigue, metabolism-improving, poor blood flow-improving, fat combustion and/or lipolysis), supplementary one, vitamin tablet and nutrient, with any difficulty in refraining from having those after the consent. (2) Subjects who have any difficulty in refraining from taking steadily (not less than 3 times a week) in affecting medicines (e.g., lipid metabolism), during this trial. (3) Subjects with any possibility of hindrance to this trial, owing to their allergic rhinitis. (4) Subjects with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area, at the consent. (5) Subjects who take excessive alcohol. (6) Subjects having a habit of smoking. (7) Subjects who are now under other clinical tests, or partook in those within 4 weeks before this trial. (8) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (9) Pregnant, possibly pregnant, or lactating women. (10) Subjects suffering from severe anemia. (11) Subjects having drug and/or food allergy. (12) Subjects who donated over 0.2 L of their whole blood and/or blood components within a month before this trial. (13) Males who donated their whole blood (0.4 L) within the last 3 months to this trial. (14) Females who donated their whole blood (0.4 L) within the last 4 months to this trial. (15) Males who will be collected in total of their blood (1.2 L) within the last 12 months, after adding the blood amounts planning to be sampled in this trial. (16) Females who will be collected in total of their blood (0.8 L) within the last 12 months, after adding the blood amounts planning to be sampled in this trial. (17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory quotient, and fat oxidation amount | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Energy expenditure level 2. Total-Cholesterol 3. Triglyceride 4. High Density Lipoprotein-Cholesterol 5. Low Density Lipoprotein-Cholesterol 6. Non-Esterified Fatty Acid 7. Salivary cortisol 8. Back surface temperature 9. Visual Analogue Scale (fatigue feeling) | — |
Countries
Japan
Contacts
CPCC Company Limited Clinical Planning Department