Healthy subjects
Conditions
Interventions
Test food A: 8 tablets/day for 1 week
Test food B: 2 tablets/day for 1 week
Test food C: 1 tablets/day for 1 week
Sponsors
HUMA R&D CORP
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese females aged 20 to 40 years of age at the time of the informed consent. 2)Subject with systolic blood pressure less than 130 mmHg at SCR. 3)Subject who is currently aware of the edema of lower limbs. 4)Subject who has understood the purpose of the study,and agreed to participate by signing the written informed consent.
Exclusion criteria
Exclusion criteria: 1)Subject with BMI <= 18.5 kg/m2 and >30 kg/m2. 2)Subject who is taking medication or who is currently under medical treatment. 3)Subject who is under exercise therapy or dietetic therapy. 4)Subject who has an allergy for test food (especially milk allergy) . 5)Subject who has or had a history of either medicine or alcohol dependence syndrome. 6)Subject who has or had a history of mental illness (depression) or sleep disturbance. 7)Subject whose lifestyle is extremely irregular. 8)Subject who has an unbalanced diet. 9)Subject who has serious illness or history such as immune disease, brain disease, malignant tumor, diabetes, liver disease (hepatitis), kidney disease or heart disease, thyroid disease, adrenal disease or other metabolic disease. 10)Subject who cannot stop using the health foods, supplements and medicines that may affect edema and fatigue of lower limbs such as Melilotus extract, long pepper extract, BCAA (branched chain amino acid) during the test period. 11)Subject who cannot stop using products to treat the edema of the lower limbs (pressure socks or stockings, and other tings alike) during the study period. 12)Subject who cannot stop taking food and drinks that is specified as health food or food with functional claims, that may affect the edma of the lower limbs during the study period. 13)Subject who cannot stop taking other medications (including Chinese medicine) or supplements during the study period. 14)Subject who has participated in other clinical studies within the last 3 months or is planning to participate in other clinical studies during the study period. 15)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 16)Subject who cannot keep the daily records. 17)Subject who is considered as an inappropriate candidate by the doctor in charge.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Questionnaire for the edma of lower limbs | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event | — |
Countries
Japan
Contacts
Public ContactDaisuke Ochitani
HUMA R&D CORP Clinical Development Division
Outcome results
None listed