UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048383
Receipt number R000055148
Scientific Title Trial of the efficacy of food ingredients on cartilage volume and cartilage degeneration
Date of disclosure of the study information 2022/07/18
Last modified on 2024/07/17 08:36:24

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Basic information

Public title

Trial of the efficacy of food ingredients on cartilage volume and cartilage degeneration in healthy men and women (SWE-2021-03-HBLOCO)

Acronym

Trial of the efficacy of food ingredients on cartilage volume and cartilage degeneration

Scientific Title

Trial of the efficacy of food ingredients on cartilage volume and cartilage degeneration

Scientific Title:Acronym

Trial of the efficacy of food ingredients on cartilage volume and cartilage degeneration

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of food ingredients on cartilage volume and cartilage degeneration

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

change rate of cartilage volume

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

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of the test foods (48 weeks)

Interventions/Control_2

Intake of the control foods (48 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

64 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Healthy men and women aged 40 to 64 years.
2) Person who has knee pain.
3) Person who can understand the purpose and content of this study and agree in writing to participate in this study.

Key exclusion criteria

1) Presence of disease in locomotor organs affecting the efficacy assessment of this study.
2) Person whose keep irregular hours such as shift work.
3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine.
4) Presence of previous and present serious disease such as cardiac affection, liver disorder, kidney disorder, cardiovascular disorder, lung disorder, diabetes mellitus.
5) Investigator's judgment for other reason.

Target sample size

94


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Watanabe

Organization

Suntory Wellness Limited

Division name

Institute For Health Care Science

Zip code

619-0284

Address

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

TEL

050-3182-0593

Email

H_Watanabe@suntory.co.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Otsuka

Organization

Suntory Wellness Limited

Division name

Institute For Health Care Science

Zip code

619-0284

Address

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

TEL

050-3182-0671

Homepage URL


Email

Yuta_Otsuka@suntory.co.jp


Sponsor or person

Institute

Suntory Wellness Limited

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

nakagawa.akiko297@eps.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

2022 Year 07 Month 18 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

94

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

2022 Year 06 Month 29 Day

Date of IRB

2022 Year 06 Month 24 Day

Anticipated trial start date

2022 Year 07 Month 19 Day

Last follow-up date

2023 Year 12 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 07 Month 15 Day

Last modified on

2024 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055148