UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029712 |
|---|---|
| Receipt number | 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 | 2019/09/15 08:32:57 |
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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 | Isao |
| Middle name | |
| Last name | Saito |
Organization
Ehime University Graduate School of Medicine
Division name
Department of Basic Nursing and Health Science
Zip code
791-0295
Address
Shizukawa, Toon, Ehime
TEL
089-960-5437
saito.isao.mh@ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsu |
| Middle name | |
| Last name | Kinoshita |
Organization
Institute of Community Life Sciences Co., Ltd.
Division name
Social Epidemiology Institute
Zip code
791-0243
Address
1383-2 Hiraimachi, Toon, Ehime
TEL
089-904-7811
Homepage URL
tetsu.prospective@gmail.com
Sponsor or person
Institute
Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
Institutional Review Board of Ehime University Hospital
Address
Shitukawa, Toon, Ehime
Tel
0899605172
rinri@m.ehime-u.ac.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
| 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
76
Results
-
Results date posted
| 2019 | Year | 09 | Month | 15 | Day |
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
| 2017 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
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
| 2019 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033328
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
