UMIN-CTR Clinical Trial

Public title

A study of the effect of the food ingredients on muscle strength in human lower limb.

Acronym

A study of the effect of the food ingredients on muscle strength in human lower limb.

Scientific Title

A study of the effect of the food ingredients on muscle strength in human lower limb.

Scientific Title:Acronym

A study of the effect of the food ingredients on muscle strength in human lower limb.

Region

Japan

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effect of the food ingredients on muscle strength in human lower limb.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The stage of the locomotive syndrome risk based on the stand-up test at the 12th week of intake.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Supplement containing food
ingredients such as glucosamine, 12 weeks.

Interventions/Control_2

Supplement not containing food
ingredients such as glucosamine, 12 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

55

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Women and men aged 55 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, especially who begins declining muscle strength in lower limb and deteriorating physical condition and lifestyles
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 2-4
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 history of osseous or articular diseases other than OA within the past 3 months
7) Presence of disease in locomotor organs that affects the efficacy assessment of this study
8) Use of product affecting the data of this study, such as medicine, food for specified health use, or health 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 present heart disorder, liver disorder, kidney disorder, diabetes mellitus, or obesity, with previous or present cardiac disorder, or with allergy to the study foods
14) Investigator's judgment for other reason

Target sample size

140

Name of lead principal investigator

1st name
Middle name
Last name	Junichi Nakamura

Organization

Suntory MONOZUKURI Expert Limited

Division name

R&D Support Department HE Center

Zip code

Address

2-3-3 Daiba, Minato-ku, Tokyo, Japan

TEL

03-5579-1277

Email

Junichi_Nakamura@suntory.co.jp

Name of contact person

1st name
Middle name
Last name	Akifumi Maeda

Organization

Suntory MONOZUKURI Expert Limited

Division name

R&D Support Department HE Center

Zip code

Address

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

TEL

050-3182-0719

Homepage URL

Email

Akifumi_Maeda@suntory.co.jp

Institute

Suntory MONOZUKURI Expert Limited

Institute

Department

Personal name

Organization

Suntory Wellness Limited

Organization

Division

Category of Funding Organization

Profit organization

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

2019

Year

06

Month

29

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

2017

Year

11

Month

09

Day

Date of IRB

Anticipated trial start date

2017

Year

11

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

10

Month

27

Day

Last modified on

2019

Year

02

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033974