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
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
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
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
