UMIN-ICDS Clinical Trial

Public title

Effects of a dairy ingredient on subjective symptoms in healthy subjects: a randomized, double-blind, placebo-controlled trial.

Acronym

Effects of a dairy ingredient on subjective symptoms in healthy subjects.

Scientific Title

Effects of a dairy ingredient on subjective symptoms in healthy subjects: a randomized, double-blind, placebo-controlled trial.

Scientific Title:Acronym

Effects of a dairy ingredient on subjective symptoms in healthy subjects.

Region

Japan

Condition

None (Healthy subjects)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effect of a dairy ingredient on subjective symptoms.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Subjective symptoms

Key secondary outcomes

Immune indices

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of dairy ingredient for 12 weeks.

Interventions/Control_2

Ingestion of placebo for 12 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Subjects between 18 to 65 years old.

Key exclusion criteria

1)Subjects who regularly consume foods containing a dairy ingredient to be evaluated.
2)Subject who plans or wish to get vaccinated or donate blood during the test period.
3)Extremely heavy drinkers (more than 60g/day of alcohol).
4)Subjects who can not sleep at night due to irregular work or other reasons.
5)Subjects who take medicines or functional foods during the pre-test period, which might affect their subjective symptoms and/or immune function.
6)Subjects who can not stop taking medicines or functional foods during the test period, which might affect their subjective symptoms and/or immune function.
7)Subjects who have serious disease in the liver, kidney heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these.
8)Subjects having chronic disorders.
9)Subjects who are positive in the pathogen test.
10)Subjects who need the application of medicine containing steroids.
11)Subjects having a milk allergy.
12)Subjects who have medical history of drug allergy or severe food ones.
13)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study.
14)Subjects who donated 400 mL of their blood within 12 weeks before the beginning of test-food intakes, or not less than 200 mL of their blood during the pre-test period.
15)Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background, physical observations, medical checkup, physical/clinical examination, and so on.

Target sample size

160

Name of lead principal investigator

1st name	Masahiko
Middle name
Last name	Kurokawa

Organization

Kyushu University of Health and Welfare

Division name

Graduate School of Clinical Pharmacy

Zip code

882-8508

Address

1714-1, Yoshino, Nobeoka, Miyazaki

TEL

982-23-5574

Email

b2mk@phoenix.ac.jp

Name of contact person

1st name	Masahiko
Middle name
Last name	Kurokawa

Organization

Kyushu University of Health and Welfare

Division name

Graduate School of Clinical Pharmacy

Zip code

882-8508

Address

1714-1, Yoshino, Nobeoka, Miyazaki

TEL

982-23-5574

Homepage URL

Email

b2mk@phoenix.ac.jp

Institute

Kyushu University of Health and Welfare

Institute

Department

Personal name

Organization

Morinaga Milk Industry Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board at Kyushu University of Health and Welfare

Address

1714-1, Yoshino, Nobeoka, Miyazaki

Tel

982-23-5574

Email

b2mk@phoenix.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

06

Month

19

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

2022

Year

06

Month

10

Day

Date of IRB

2022

Year

06

Month

10

Day

Anticipated trial start date

2022

Year

06

Month

20

Day

Last follow-up date

2022

Year

11

Month

11

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

06

Month

17

Day

Last modified on

2022

Year

12

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054789