UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046681
Receipt number R000053133
Scientific Title Study of ingestion of protein powder
Date of disclosure of the study information 2022/01/20
Last modified on 2022/07/25 12:37:42

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Basic information

Public title

Study of ingestion of protein powder

Acronym

Study of ingestion of protein powder

Scientific Title

Study of ingestion of protein powder

Scientific Title:Acronym

Study of ingestion of protein powder

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of test food on the body

Basic objectives2

Others

Basic objectives -Others

Absorption kinetics after food ingestion

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Plasma amino acids, BAP, d-ROMs, testosterone, glucose and irisin concentration and questionnaire

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Ingestion of test food (1 week)

Interventions/Control_2

Ingestion of placebo food (1 week)

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

18 years-old <=

Age-upper limit

30 years-old >

Gender

Male

Key inclusion criteria

Male students belonging to University of Tsukuba who are healthy and not suffered from a chronic malady.
Individuals whose written informed consent has been obtained.

Key exclusion criteria

Individuals who have possibility of allergy symptoms onset by the test food and who cause allergic symptoms in foods and medicines.
Individuals who are a smoker.
Individuals who have a habit to ingest food containing test food ingredients on a daily basis.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Naomi
Middle name
Last name Omi

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8574

Address

1-1-1, Tennou dai, Tsukuba city

TEL

029-853-6319

Email

omi.naomi.gn@u.tsukuba.ac.jp


Public contact

Name of contact person

1st name Naomi
Middle name
Last name Omi

Organization

University of Tsukuba

Division name

Faculty of Health and Sport Sciences

Zip code

305-8574

Address

1-1-1, Tennou dai, Tsukuba city

TEL

029-853-6319

Homepage URL


Email

omi.naomi.gn@u.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

MORINAGA & 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

Research ethics committee,Faculty of Health and Sport Sciences,University of Tsukuba

Address

1-1-1 Tennodai, Tsukuba,Ibaraki

Tel

029-853-2571

Email

tg-kenkyurinri@un.tsukuba.ac.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 01 Month 20 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

Completed

Date of protocol fixation

2021 Year 11 Month 02 Day

Date of IRB

2021 Year 12 Month 22 Day

Anticipated trial start date

2022 Year 01 Month 20 Day

Last follow-up date

2023 Year 03 Month 31 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 01 Month 20 Day

Last modified on

2022 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053133


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name