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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-UMIN000028862 |
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Date of registration:
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08/09/2017 |
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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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The health benefits of test food (HBF2017-01): a randomized double-blind, paralled-group, placebo-controlled study
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Scientific title:
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The health benefits of test food (HBF2017-01): a randomized double-blind, paralled-group, placebo-controlled study - The health bebefits of test food (HBF2017-01) |
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Date of first enrolment:
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2017/09/11 |
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Target sample size:
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40 |
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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=R000033034 |
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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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Chiyo
Yoshizane |
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Address:
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675-1, Fujisaki, Naka-ku, Okayama
7028006
Japan |
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Telephone:
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086-276-3141 |
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Email:
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chiyo.yoshizane@hb.nagase.co.jp |
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Affiliation:
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Hayashibara CO., LTD. R&D Division, Development Unit |
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Name:
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Chiyo
Yoshizane |
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Address:
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675-1, Fujisaki, Naka-ku, Okayama
Japan |
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Telephone:
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086-276-3141 |
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Email:
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chiyo.yoshizane@hb.nagase.co.jp |
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Affiliation:
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Hayashibara CO., LTD. R&D Division, Development Unit |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)Subjects with medical history of sever disorders 2)Pregnant or have possibility to become pregnant during the study or lactating women 3)Subjects who judged as unsuitable for this study by the principal investigator for any reasons 4)Subjects who are being treated with hyperglycemia
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 Japanease adults
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Intervention(s)
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Oral ingestion of the test food(HBF2017-01) twice a day(after lunch and after dinner) for 12 weeks
Oral ingestion of the placebo control food twice a day(after lunch and after dinner) for 12 weeks
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Primary Outcome(s)
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1.Blood glucose after a 2-h OGTT * Measuring: at 0 and 12 weeks after ingestion
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Secondary Outcome(s)
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1.Body weight, BMI, Body fat, Truncal fat, Blood pressure, Abdominal circumference, Waist circumference * Measuring: at 0,8 and 12 weeks after ingestion 2. Blood glucose, Insulin, HbA1c, ALT, AST, gamma-GTP, TG, Total choresterol, HDLchoresterol, LDLchoresterol, PAI-1 * Measuring: at 0 and 12 weeks after ingestion
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Source(s) of Monetary Support
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None
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Ethics review
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Status: YES
Approval date:
Contact:
HB96301@hb.nagase.co.jp
The Ethics Committee of Hayashibara Co., Ltd.
086-276-3141
HB96301@hb.nagase.co.jp
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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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