UMIN-CTR Clinical Trial

Public title

Trial of the effect of food ingredients on mobility and muscle strength

Acronym

Trial of the effect of food ingredients on mobility and muscle strength

Scientific Title

Trial of the effect of food ingredients on mobility and muscle strength

Scientific Title:Acronym

Trial of the effect of food ingredients on mobility and muscle strength

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of food ingredients on mobility and muscle strength

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The stage of the locomotive syndrome risk based on three indices for assessing risk of locomotive syndrome at 8th week, 12th week and 16th week of intake

Key secondary outcomes

Measured value of three indices for assessing risk of locomotive syndrome at 8th week, 12th week and 16th week of intake

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Supplement containing food ingredients such as glucosamine, 16 Weeks

Interventions/Control_2

Supplement not containing food ingredients such as glucosamine, 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

Age-lower limit

40

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Women and men aged 40 to 74 years at the time of acquisition of agreement in participating in this study
2) Presence of knee pain
3) Person who begins declining in mobility
4) Person who can come to the medical organization for the measurement at the date of visiting
5) Person who can understand the purpose and content of this study and agree in writing to participate in this study

Key exclusion criteria

1) Kellgren-Lawrence grades II-IV

2) Presence of hyperuricemia
3) Presence of rheumatoid arthritis that may cause joint pain
4) Surgical treatment of knee joint(s) needed or undergone
5) Need for pharmacological articular treatments during the study period
6) Presence of disease in locomotor organs affecting the efficacy assessment of this study
7) Presence of history of osseous or articular diseases other than OA within the past 3 months
8) Use of product affecting the data of this study, such as medicine, food for specified health use, supplement, diet food
9) Daily use of a cane or a supporter
10) Daily use of hot spa or massage therapy
11) Daily or occasional vigorous exercise
12) Female in pregnancy, lactation and scheduled pregnancy period
13) With previous and present serious disease such as liver disorder, kidney disorder, cardiac affection, lung disorder, digestive disorder, organ disorder, diabetes mellitus, food allergy
14) Investigator's judgment for other reason

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Takayuki Izumo

Organization

Suntory Wellness Limited

Division name

Institute for Health Care Science

Zip code

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan

TEL

050-3182-0630

Email

Takayuki_Izumo@suntory.co.jp

Name of contact person

1st name
Middle name
Last name	Noriyuki Kanzaki

Organization

Suntory Wellness Limited

Division name

Institute for Health Care Science

Zip code

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, 619-0284, Japan

TEL

050-3182-0666

Homepage URL

Email

Noriyuki_Kanzaki@suntory.co.jp

Institute

Suntory Wellness Limited

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

10

Month

27

Day

Date of IRB

Anticipated trial start date

2016

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

28

Day

Last modified on

2017

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028312