Effect of the supplement on edma of the lower limbs in healthy females - A randomized controlled trial

Not Applicable

• Conditions: Healthy subjects

• Registration Number: JPRN-UMIN000037409
• Lead Sponsor: HUMA R&D CORP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-22
• Study Completion: 2019-09-06
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified