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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048087
Receipt No. R000054789
Scientific Title Effects of a dairy ingredient on subjective symptoms in healthy subjects: a randomized, double-blind, placebo-controlled trial.
Date of disclosure of the study information 2022/06/19
Last modified on 2022/06/17

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Basic information
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
Condition None (Healthy subjects)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes Subjective symptoms
Key secondary outcomes Immune indices

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Kyushu University of Health and Welfare
Institute
Department

Funding Source
Organization 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 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
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
2022 Year 06 Month 19 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 Preinitiation
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
Other related information

Management information
Registered date
2022 Year 06 Month 17 Day
Last modified on
2022 Year 06 Month 17 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054789

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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