UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033891
Receipt number R000038653
Scientific Title Evaluation of physical function in elderly subjects by botanical extract-formulated food: a randomized, double-blind, placebo-controlled study
Date of disclosure of the study information 2018/09/03
Last modified on 2019/07/09 16:42:13

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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 or person

Institute

Maruzen Pharmaceuticals Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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