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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000027405 |
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Date of registration:
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19/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial.
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Scientific title:
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Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial. - Effect of ingestion of test food on immune parameters and state of health of healthy adults in summer: a randomized, double-blinded, placebo-controlled trial. |
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Date of first enrolment:
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2017/05/22 |
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Target sample size:
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300 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031404 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Masahiko Kurokawa |
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Address:
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1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
Japan |
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Telephone:
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0982-23-5574 |
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Email:
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b2mk@phoenix.ac.jp |
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Affiliation:
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Kyushu University of Health and Welfare Department of Biochemistry, Graduate School of Clinical Pharmacy |
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Name:
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Masahiko Kurokawa |
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Address:
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1714-1 Yoshino, Nobeoka, Miyazaki, 882-8508 JAPAN
Japan |
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Telephone:
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0982-23-5574 |
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Email:
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b2mk@phoenix.ac.jp |
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Affiliation:
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Kyushu University of Health and Welfare Department of Biochemistry, Graduate School of Clinical Pharmacy |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Subjects with chronic diseases 2) Subjects in pregnancy or breast-feeding 3) Subjects with milk allergy 4) Subjects who consume test food habitually 5) Subjects who have a history of serious disorders in liver, kidney, heart, lung, gastro-intestine, blood, endocrine system, or metabolic system etc. 6) Subjects who are judged inappropriate to this trial by the investigator
Age minimum:
20years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Healthy Adults
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Intervention(s)
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Ingestion of test food (high dose) for 12 weeks
Ingestion of test food (low dose) for 12 weeks
Ingestion of placebo for 12 weeks
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Primary Outcome(s)
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Immune parameters (natural killer cell cytotoxicity, Neutrophil phagocytic capacity, sIgA) State of health in summer (infectious diseases etc)
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Secondary Outcome(s)
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Balance of the autonomic nervous system Cortisol
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Source(s) of Monetary Support
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Morinaga Milk Industry Co., Ltd.
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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