UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study
Acronym	Evaluation of physical function in elderly subjects by botanical extract -formulated food
Scientific Title	Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym	Evaluation of physical function in elderly subjects by botanical extract -formulated food
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of intake of botanical extract-formulated food for 8 weeks on physical function in elderly subjects aged 65-74.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	6-Minute Walk Test
Key secondary outcomes	Timed Up and Go Test Chair stand Test Handgrip strength Test Sit and Reach Test Profile of Mood States 2nd Edition Borg scale VAS (Visual analogue scale) Clinical examination

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	Intake of test food for 8 weeks
Interventions/Control_2	Intake of placebo food for 8 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	65 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Males and females aged 65-74 years 2. Subjects who can carry out"Timed Up and Go Test" 3. Subjects who can carry out"6-Minute Walk Test" 4. Subjects who can visit the medical institution at the scheduled visit date 5. Subjects who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria	1. Subjects with heart disease 2. Subjects with serious diseases (diabetes,hypertension, hyperlipidemia, liver disease, or kidney damage) 3. Subjects with respiratory diseases 4. Subjects who have experienced dizziness, syncope, and transient sight loss 5. Subjects with musculoskeletal disorders limiting physical activities 6. Subjects who take medicine affecting heart rate 7. Subjects who have allergy related to the test foods 8. Subjects who had a habit to ingest medicine, foods for specified health uses, and foods with function claims 9. Subjects who are difficult to swallow 10. Subjects who are ineligible due to physician's judgment
Target sample size	34

Research contact person
Name of lead principal investigator	1st name Hiromi Middle name Last name Miyawaki
Organization	Miyawaki Orthopedic Clinic
Division name	Hospital director
Zip code	061-1431
Address	3-1-6 Ariake, Eniwa, Hokkaido, Japan
TEL	0123-33-4026
Email	Miyawaki1571@north-wind.ne.jp

Public contact
Name of contact person	1st name Shimpei Middle name Last name Tomita
Organization	New drug research center, Inc.
Division name	Clinical Research Dept.
Zip code	061-1445
Address	452-1Toiso,Eniwa-shi,Hokkaido, Japan
TEL	0123-34-0412
Homepage URL
Email	s-tomita@ndrcenter.co.jp

Sponsor
Institute	Maruzen Pharmaceuticals Co., Ltd.
Institute
Department

Funding Source
Organization	Maruzen Pharmaceuticals Co., Ltd.
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	Miyawaki Orthopedic Clinic Clinical Trial Review Committee
Address	3-1-6 Ariakecho, Eniwa City, Hokkaido
Tel	0123-33-4026
Email	d-kameda@mediffom.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	2018 Year 09 Month 03 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	34
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	2018 Year 07 Month 09 Day
Date of IRB	2018 Year 07 Month 09 Day
Anticipated trial start date	2018 Year 09 Month 04 Day
Last follow-up date	2018 Year 11 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 08 Month 25 Day
Last modified on	2019 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038653

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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