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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025347
Receipt No. R000029177
Scientific Title An exploratory study to evaluate the efficacy of the single ingestion of milk protein hydrolysate on cerebral activity.
Date of disclosure of the study information 2017/01/10
Last modified on 2017/12/22

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Basic information
Public title An exploratory study to evaluate the efficacy of the single ingestion of milk protein hydrolysate on cerebral activity.
Acronym Effect of milk protein hydrolysate on cerebral activity.
Scientific Title An exploratory study to evaluate the efficacy of the single ingestion of milk protein hydrolysate on cerebral activity.
Scientific Title:Acronym Effect of milk protein hydrolysate on cerebral activity.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of milk protein hydrolysate on cerebral activity in adult.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reaction time and correct answer ratio against cognitive tasks
The cerebral blood flow
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Milk protein hydrolysate
40mg/kg, single dose
Interventions/Control_2 Milk protein
40mg/kg, single dose
Interventions/Control_3 Dietary fiber (Placebo)
40mg/kg, single dose
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 and Female
Key inclusion criteria 1) More than 20 years and less than 65 years old
2) Subjects who have no problems in daily life.
Key exclusion criteria 1) Subjects with dementia for cerebrovascular disease or Alzheimer's disease.
2) Subjects with severe diseases or medical histories
3) Subjects with milk allergy
4) Subjects continuously using supplements that may influence cerebral function; e.g. DHA, EPA, catechin.
5) Subjects who are judged inappropriate for the study by the physician.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Takeda
Organization Morinaga Milk Industry Co., LTD.
Division name Wellness & Nutrition Science Institute, R&D Division
Zip code
Address 1-83,5-Chome, Higashihara, Zama-City, Kanagawa-pref.
TEL 046-252-3050
Email ya_taked@morinagamilk.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohiko Nakamura, Noriko Saito
Organization Morinaga Milk Industry Co., LTD.
Division name Wellness & Nutrition Science Institute, R&D Division
Zip code
Address 1-83,5-Chome, Higashihara, Zama-City, Kanagawa-pref.
TEL 046-252-3050
Homepage URL
Email hi_nakam@morinagamilk.co.jp

Sponsor
Institute Morinaga Milk Industry Co., LTD.
Institute
Department

Funding Source
Organization Wellness & Nutrition Science Institute,
R&D Division,
Morinaga Milk Industry 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
Address
Tel
Email

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
2017 Year 01 Month 10 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
2016 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 11 Day
Last follow-up date
2017 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 09 Month 07 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2017 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029177

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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