UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000018978 |
| Receipt No. | R000020498 |
| Scientific Title | Study on effects of a plant derived processed product on postprandial triglyceride |
| Date of disclosure of the study information | 2015/09/11 |
| Last modified on | 2019/07/26 (Ver. 8) |
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| Basic information | ||
| Public title | Study on effects of a plant derived processed product on postprandial triglyceride
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| Acronym | Study on effects of a plant derived processed product on postprandial triglyceride
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| Scientific Title | Study on effects of a plant derived processed product on postprandial triglyceride
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| Scientific Title:Acronym | Study on effects of a plant derived processed product on postprandial triglyceride
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| Region |
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| Condition | ||
| Condition | healthy subject
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| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | To investigate effects of a food product on postprandial triglyceride
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| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | postprandial triglyceride
(blood collection : fasting and 2,3,4,6 hours after the test meal) |
| Key secondary outcomes | apo-B48
physical examination blood general analysis biochemical test urinalysis |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Cross-over |
| 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 | 6 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | placebo food (code name;C-001)
single ingestion group 1 placebo food - test food 1 - test food 2 |
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| Interventions/Control_2 | placebo food (code name;C-001)
single ingestion group 2 placebo food - test food 2 - test food 1 |
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| Interventions/Control_3 | test food 1 (code name;A-001)
single ingestion group 3 test food 1 - placebo food - test food 2 |
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| Interventions/Control_4 | test food 1 (code name;A-001)
single ingestion group 4 test food 1 - test food 2 - placebo food |
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| Interventions/Control_5 | test food 2 (code name;A-002)
single ingestion group 5 test food 2 - placebo food - test food 1 |
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| Interventions/Control_6 | test food 2 (code name;A-002)
single ingestion group 5 test food 2 - test food 1 - placebo food |
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| 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, Fasting triglyceride >=120, and < 200mg/dL
2, Aged between 35 and 64 3, BMI >= 23 and <30 kg/m2 4, Person who provides informed consent by a document |
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| Key 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. |
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| Target sample size | 43 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Kao corporation | ||||||
| Division name | Health Care Food Research Labs | ||||||
| Zip code | 131-8501 | ||||||
| Address | 2-1-3 Bunka Sumida-ku Tokyo | ||||||
| TEL | 03-5630-7452 | ||||||
| katsuragi.yoshihisa@kao.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | TES Holdings Co. Ltd | ||||||
| Division name | Sales department for tissue engineering and clinical research | ||||||
| Zip code | 113-0033 | ||||||
| Address | 7-3-1 Hongo Bunkyo-ku Tokyo | ||||||
| TEL | 03-5449-5120 | ||||||
| Homepage URL | |||||||
| r.shimizu@tes-h.co.jp | |||||||
| Sponsor | |
| Institute | TES Holdings Co. Ltd |
| Institute | |
| Department | |
| Funding Source | |
| Organization | KAO CORPORATION |
| 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 | Oriental Ueno medical center |
| Address | 1-20-11 Ueno Taito-ku Tokyo |
| Tel | 03-5816-0711 |
| info@tes-h.co.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 | https://www.ncbi.nlm.nih.gov/pubmed/28202845 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/28202845 | ||||||
| Number of participants that the trial has enrolled | 48 | ||||||
| Results | There was a significant difference in the primary outcome |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | men and women between 35 and 64 year of age. fasting blood TG levels of 120 to 199 mg/dL |
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| Participant flow | 46 participants completed and 38 subjects were incorporated into the analyses |
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| Adverse events | No adverse effect related to the test diets |
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| Outcome measures | postprandial TG level |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| 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 of closure to data entry | |||||||
| Date trial data considered complete | |||||||
| 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://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020498 |
