UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the supplement on edma of the lower limbs in healthy females - A randomized controlled trial -
Acronym	Effect of the supplement on edma of the lower limbs in healthy females
Scientific Title	Effect of the supplement on edma of the lower limbs in healthy females - A randomized controlled trial -
Scientific Title:Acronym	Effect of the supplement on edma of the lower limbs in healthy females
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of supplement on edma of the lower limbs in healthy females aged between 20 and 40 years old.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire for the edma of lower limbs
Key secondary outcomes	Adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test food A: 8 tablets/day for 1 week
Interventions/Control_2	Test food B: 2 tablets/day for 1 week
Interventions/Control_3	Test food C: 1 tablets/day for 1 week
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	40 years-old >
Gender	Female
Key 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.
Key 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.
Target sample size	102

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health Science Research Center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3510
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	102
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 06 Month 20 Day
Date of IRB	2019 Year 07 Month 12 Day
Anticipated trial start date	2019 Year 07 Month 31 Day
Last follow-up date	2019 Year 09 Month 06 Day
Date of closure to data entry	2019 Year 09 Month 09 Day
Date trial data considered complete	2019 Year 09 Month 17 Day
Date analysis concluded	2020 Year 03 Month 19 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 18 Day
Last modified on	2020 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042643