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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029712
Receipt No. R000033328
Scientific Title The Effects of Licorice Flavonoid Oil Intake with Consistent Exercise on Locomotor Function: A Randomized, Double-Blind, Placebo-Controlled Trial
Date of disclosure of the study information 2017/10/25
Last modified on 2018/05/23

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Basic information
Public title The Effects of Licorice Flavonoid Oil Intake with Consistent Exercise on Locomotor Function: A Randomized, Double-Blind, Placebo-Controlled Trial
Acronym LFO & Excercise
Scientific Title The Effects of Licorice Flavonoid Oil Intake with Consistent Exercise on Locomotor Function: A Randomized, Double-Blind, Placebo-Controlled Trial
Scientific Title:Acronym LFO & Excercise
Region
Japan

Condition
Condition Nothing
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of Licorise Flavonoid Oil (LFO) on locomotor function when the participants consume it with consistent exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10 meter walking speed with obstruction
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The participants excercise in accordance with their program and consume 1 LFO capsule per day for 16 weeks.
Interventions/Control_2 The participants excercise in accordance with their program and consume 1 placebo capsule per day for 16 weeks.
Interventions/Control_3
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
40 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria The one who
Key exclusion criteria (1)Allergic to test food
(2)Hemoglobin < 8.0 g/dl
(3)eGFR < 45
(4)AST >= 100 IU/l
(5)ALT >= 100 IU/l
(6)gamma-GT >= 200 IU/l
(7)Serum albmumin < 3.0 g/dl
(8)HbA1c >= 8.0%
(9)pregnant
(10)The one who need stick for walking
(11)The one manager decide
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Saito
Organization Ehime University Graduate School of Medicine
Division name Department of Basic Nursing and Health Science
Zip code
Address Shizukawa, Toon, Ehime
TEL 089-960-5437
Email saito.isao.mh@ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsu Kinoshita
Organization Community Life Sciences Co., Ltd.
Division name Institute of Social Epidemiology
Zip code
Address 1383-2 Hiraimachi, Toon, Ehime
TEL 089-904-7811
Homepage URL
Email tetsu.prospective@gmail.com

Sponsor
Institute Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization Kaneka 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
Address
Tel
Email

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
2017 Year 10 Month 25 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
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
2017 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 25 Day
Last modified on
2018 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033328

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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