UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000060063
Receipt number R000068692
Scientific Title PrePost Survey of Exercise plus Protein Program in Healthy Adults
Date of disclosure of the study information 2025/12/12
Last modified on 2025/12/12 11:14:02

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Basic information

Public title

PrePost Survey of Exercise plus Protein Program in Healthy Adults

Acronym

PrePost Survey of Exercise plus Protein Program

Scientific Title

PrePost Survey of Exercise plus Protein Program in Healthy Adults

Scientific Title:Acronym

PrePost Survey of Exercise plus Protein Program

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the impact of the Life Motivate Program on the physical and mental health status and quality of life of healthy adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in physical and mental health status resulting from participation in the Life Motivate Program.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Healthy adults who voluntarily decided to participate in the Life Motivate Program.
2.Individuals who have fully understood the study details and have provided informed consent to participate of their own free will.

Key exclusion criteria

None

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yukikazu
Middle name
Last name Kamada

Organization

Nestle Japan Ltd

Division name

Nestle Health Science Company

Zip code

140-0002

Address

Tennozu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo

TEL

070-2278-7597

Email

Yukikazu.Kamada@jp.nestle.com


Public contact

Name of contact person

1st name Hiroki
Middle name
Last name Takano

Organization

Nestle Japan Ltd

Division name

Nestle Health Science Company

Zip code

140-0002

Address

Tennozu Ocean Square 20F, 2-2-20 Higashi-Shinagawa, Shinagawa-ku, Tokyo

TEL

070-2448-5234

Homepage URL


Email

Hiroki.takano@jp.nestle.com


Sponsor or person

Institute

Nestle Health Science Company, Nestle Japan Ltd.

Institute

Department

Personal name



Funding Source

Organization

Nestle Japan 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

Shiba Palace Clinic Ethics Review Committee

Address

DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, JAPAN

Tel

03-5408-1599

Email

shiba_palace@s-palace-clinic.com


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

2025 Year 12 Month 12 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


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

Preinitiation

Date of protocol fixation

2025 Year 12 Month 09 Day

Date of IRB

2025 Year 12 Month 11 Day

Anticipated trial start date

2026 Year 01 Month 13 Day

Last follow-up date

2026 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2025 Year 12 Month 12 Day

Last modified on

2025 Year 12 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068692