UMIN-CTR Clinical Trial

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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