UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An exploratory study to evaluate the efficacy of the single ingestion of milk protein hydrolysate on cerebral activity.
Title of the study (Brief title)	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	Yasuhiro Takeda
Organization	Morinaga Milk Industry Co., LTD.
Division name	Wellness & Nutrition Science Institute, R&D Division
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	Hirohiko Nakamura, Noriko Saito
Organization	Morinaga Milk Industry Co., LTD.
Division name	Wellness & Nutrition Science Institute, R&D Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029177