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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-UMIN000018978 |
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Date of registration:
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11/09/2015 |
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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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Study on effects of a plant derived processed product on postprandial triglyceride
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Scientific title:
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Study on effects of a plant derived processed product on postprandial triglyceride - Study on effects of a plant derived processed product on postprandial triglyceride |
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Date of first enrolment:
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2015/09/11 |
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Target sample size:
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43 |
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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=R000020498 |
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Study type:
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Interventional |
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Study design:
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Cross-over 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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Ryoma
Ryoma |
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Address:
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7-3-1 Hongo Bunkyo-ku Tokyo
113-0033
Japan |
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Telephone:
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03-5449-5120 |
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Email:
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r.shimizu@tes-h.co.jp |
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Affiliation:
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TES Holdings Co. Ltd Sales department for tissue engineering and clinical research |
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Name:
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Yoshihisa
Katuragi |
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Address:
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2-1-3 Bunka Sumida-ku Tokyo
Japan |
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Telephone:
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03-5630-7452 |
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Email:
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katsuragi.yoshihisa@kao.co.jp |
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Affiliation:
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Kao corporation Health Care Food Research Labs |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1, Person who is difficult to participate the study due to dysfunctions of liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions. 2, Person who takes medication for glucose or fat metabolism, or hypertension. 3, Person who was given surgery for a disease or an injury 2 months prior to the study. 4, Individual intakes supplements or the food for specific use of health authorized the government. 5, Person had allergy against any constituents in the test diet. 6, Person who is used to take test food. 7, Individual experienced unpleasant feeling during blood drawing. 8, Person who donated 200mL or more of blood within a month prior to the study. 9, Heavy smoker 10, Person who don't record of meal recoding for 9 days 11, Shift worker 12, Person who is planned long term business trip or travel of a domestic or foreign country in study period 13, Person who can't accept to be accessed their medical records. 14, Person who have participated in other clinical studies. 15, Person who are expecting pregnancy or lactation period. 16, Person who are considered inappropriate by medical doctors.
Age minimum:
35years-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 subject
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Intervention(s)
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placebo food (code name;C-001) single ingestion group 1 placebo food - test food 1 - test food 2
placebo food (code name;C-001) single ingestion group 2 placebo food - test food 2 - test food 1
test food 1 (code name;A-001) single ingestion group 3 test food 1 - placebo food - test food 2
test food 1 (code name;A-001) single ingestion group 4 test food 1 - test food 2 - placebo food
test food 2 (code name;A-002) single ingestion group 5 test food 2 - placebo food - test food 1
test food 2 (code name;A-002) single ingestion group 5 test food 2 - test food 1 - placebo food
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Primary Outcome(s)
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postprandial triglyceride (blood collection : fasting and 2,3,4,6 hours after the test meal)
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Secondary Outcome(s)
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apo-B48 physical examination blood general analysis biochemical test urinalysis
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Source(s) of Monetary Support
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KAO CORPORATION
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Ethics review
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Status: YES
Approval date: 11/08/2015
Contact:
info@tes-h.co.jp
Oriental Ueno medical center
03-5816-0711
info@tes-h.co.jp
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