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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038388
Receipt No. 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 2019/10/25

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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
Institute Morinaga Milk Industry Co., LTD.
Institute
Department

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
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
2019 Year 10 Month 03 Day
Date of IRB
2019 Year 10 Month 17 Day
Anticipated trial start date
2019 Year 11 Month 06 Day
Last follow-up date
2020 Year 10 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
2019 Year 10 Month 25 Day
Last modified on
2019 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.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


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