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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | None (Healthy subjects) | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 160 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
b2mk@phoenix.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |