UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038388
Receipt number R000043746
Scientific Title A randomized open label, placebo controlled, cross-over trial to evaluate the digestion and absorption of milk protein in healthy males.
Date of disclosure of the study information 2019/11/06
Last modified on 2021/11/05 10:16:27

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Basic information

Public title

A trial to evaluate the digestion and absorption of milk protein

Acronym

A trial to evaluate the digestion and absorption of milk protein

Scientific Title

A randomized open label, placebo controlled, cross-over trial to evaluate the digestion and absorption of milk protein in healthy males.

Scientific Title:Acronym

A randomized open label, placebo controlled, cross-over trial to evaluate the digestion and absorption of milk protein in healthy males.

Region

Japan


Condition

Condition

Healthy males

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the digestion and absorption of milk protein in healthy males.

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 and urea concentration, cross sectional area of gastric antrum

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single dose administration of milk protein A 30 g as a protein content plus carbohydrate solution(total 240 kcal, 350 g)

Interventions/Control_2

Single dose administration of milk protein B 30 g as a protein content plus carbohydrate solution(total 240 kcal, 350 g)

Interventions/Control_3

Single dose administration of milk protein C 30 g as a protein content plus carbohydrate solution(total 240 kcal, 350 g)

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male

Key inclusion criteria

A healthy male aged between 20 and 65 years

Key exclusion criteria

1) Subjects with a milk allergy.
2) Subjects with a lactose intolerance
3) Subjects who have a smoking habit.
4) Subjects who are under treatment or have a severe medical history for liver, kidney, heart, lung, digestive system, blood, endocrine or metabolic diseases.
5)Subjects who are regarded as inappropriate participation for the study by the investigator.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Takeda

Organization

Morinaga Milk Industry Co., LTD.

Division name

R&D Division Wellness&Nutrition Science Institute

Zip code

252-8583

Address

1-83, 5-Chome, Higashihara, Zama-city, Kanagawa Pref. Japan

TEL

046-252-3046

Email

ya_taked@morinagamilk.co.jp


Public contact

Name of contact person

1st name Yasuyuki
Middle name
Last name Sakata

Organization

Morinaga Milk Industry Co., LTD.

Division name

R&D Division Wellness&Nutrition Science Institute

Zip code

252-8583

Address

1-83, 5-Chome, Higashihara, Zama-city, Kanagawa Pref. Japan

TEL

046-252-3046

Homepage URL


Email

ys-sakata@morinagamilk.co.jp


Sponsor or person

Institute

Morinaga Milk Industry Co., LTD.

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

Japan Conference of Clinical Research

Address

1-13-23 Minamiikebukuro, Toshima-ku, Tokyo

Tel

03-6868-7022

Email

None


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

森永乳業株式会社 研究本部 健康栄養科学研究所(神奈川県)


Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 06 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

10

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

2019 Year 10 Month 03 Day

Date of IRB

2019 Year 10 Month 17 Day

Anticipated trial start date

2019 Year 11 Month 29 Day

Last follow-up date

2020 Year 02 Month 19 Day

Date of closure to data entry

2020 Year 12 Month 22 Day

Date trial data considered complete

2020 Year 12 Month 25 Day

Date analysis concluded

2021 Year 03 Month 12 Day


Other

Other related information



Management information

Registered date

2019 Year 10 Month 25 Day

Last modified on

2021 Year 11 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043746


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name