UMIN-CTR Clinical Trial

Public title

The effects of milk protein drink on appetite and appetite-related blood components

Acronym

The effects of milk protein drink on appetite and appetite-related blood components

Scientific Title

The effects of milk protein drink on appetite and appetite-related blood components

Scientific Title:Acronym

The effects of milk protein drink on appetite and appetite-related blood components

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To evaluate the effect of milk protein drink or acidic milk protein drink on appetite and appetite-related components

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1)Food intake
2)Energy intake
3)Nutrition intake

Key secondary outcomes

1)Blood parameter regarding appetite
2)Subjective hunger score by visual analog scale(VAS)
3)Appetite-related protein profiling by proteomic analysis
4)Appetite-related circulating microRNAs profiling by microarray

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

6

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink

Interventions/Control_2

Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink -> Washout more than 2days-> Single ingestion of acidic milk protein drink

Interventions/Control_3

Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink

Interventions/Control_4

Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of carbohydrate drink-> Washout more than 2days-> Single ingestion of milk protein drink

Interventions/Control_5

Single ingestion of carbohydrate drink -> Washout more than 2days-> Single ingestion of milk protein drink-> Washout more than 2days-> Single ingestion of acidic milk protein drink

Interventions/Control_6

Single ingestion of carbohydrate drink-> Washout more than 2days-> Single ingestion of acidic milk protein drink-> Washout more than 2days-> Single ingestion of milk protein drink

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

30

years-old

>

Gender

Male

Key inclusion criteria

1)Subjects who have given written informed consent
2)Healthy males aged 20 to 30 years old

Key exclusion criteria

1)Subjects who have been regularly taking drugs, quasi drugs, health foods or supplements that may affect this study within a month prior to the start of this study
2)Subjects who are treated for diabetes
3)Subjects with serious or progressive illnesses
4)Subjects with food allergies
5)Subjects who are judged as ineligible for the study by the lead principal investigator for other reasons

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Satoshi Fujita

Organization

Ritsumeikan university

Division name

College of sports and health science

Zip code

Address

1-1-1, Nojihigashi, Kusatsu-shi, Shiga 525-8577 Japan

TEL

077-561-5229

Email

safujita@fc.ritsumei.ac.jp

Name of contact person

1st name
Middle name
Last name	Teruyuki Noma

Organization

Meiji Co., Ltd

Division name

Health Science Research Department Food Science & Technology Research Laboratories R&D Division

Zip code

Address

1-29-1, Nanakuni, Hachiouji, Tokyo 192-0919, Japan

TEL

042-632-5849

Homepage URL

Email

teruyuki.noma@meiji.com

Institute

Ritsumeikan university

Institute

Department

Personal name

Organization

Meiji Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

立命館大学（滋賀県）/Ritsumeikan university(Shiga)

Date of disclosure of the study information

2017

Year

02

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

12

Month

05

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

08

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

02

Month

07

Day

Last modified on

2018

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029921