UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000030131 |
| Receipt No. | R000034404 |
| Scientific Title | Examination of single ingestion of drink containing plant extract. A-17004 |
| Date of disclosure of the study information | 2017/11/27 |
| Last modified on | 2020/01/31 (Ver. 9) |
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| Basic information | ||
| Public title | Examination of single ingestion of drink containing plant extract. A-17004 | |
| Acronym | Examination of single ingestion of drink containing plant extract. A-17004 | |
| Scientific Title | Examination of single ingestion of drink containing plant extract. A-17004 | |
| Scientific Title:Acronym | Examination of single ingestion of drink containing plant extract. A-17004 | |
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| Condition | |||
| Condition | Healthy adults | ||
| Classification by specialty |
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| Classification by malignancy | Others | ||
| Genomic information | NO | ||
| Objectives | |
| Narrative objectives1 | To examine the effects of plant extract on vascular function. |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Skin temperature. |
| Key secondary outcomes | Peripheral blood flow and subjective evaluation. |
| 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 | YES |
| Concealment | No need to know |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | Drink containing plant extract (single ingestion)->washout period->placebo drink not containing plant extract (single ingestion) | |
| Interventions/Control_2 | Placebo drink not containing plant extract (single ingestion) ->washout period->Drink containing plant extract (single ingestion) | |
| 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 | Female | |||
| Key inclusion criteria | 1.Healthy adults
2.Person whose estradiol cycle is stable between 28 and 32 days. 3.Person who is sensitive to cold. 4.Person whose body math indexes are from 18.5 or more to 25 less than 25.0 5.Person whose diastolic blood pressures are less than 90mmHg and systolic ones less than 140mmHg. 6.Person who agrees not to ingest specified foods and supplements during the test period. |
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| Key exclusion criteria | 1.Person who has severe allergic disease as rhinitis, atopicdermatitis.
2.Person who is pregnant, lactating or planned to become pregnant during the test period. 3.Patient with vascular function disorder. 4.Person who has problems with electrocardiogram test such as arrhythmia. 5.Person who takes medicine. 6.Person who regularly goes to hospital or went to the medical institution within a month. 7.Current smoker. 8.Person who plans to participate in the other clinical studies. 9.Person who is judged as unsuitable for the study by the investigator for other reasons. |
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| Target sample size | 24 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Kao Corporation | ||||||
| Division name | R&D-Skin Care Products Research | ||||||
| Zip code | 131-8501 | ||||||
| Address | 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan | ||||||
| TEL | +81-3-5630-9581 | ||||||
| suma.akane@kao.com | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | TES Holdings Co., Ltd | ||||||
| Division name | Administrative Department of Clinical Trials | ||||||
| Zip code | 110-0015 | ||||||
| Address | Kairaku Building 6F, Higashi-ueno, Taito-ku, Tokyo 113-0033, JAPAN | ||||||
| TEL | +81-3-6801-8480 | ||||||
| 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 | Human Research Ethics Committee, Kao Corporation |
| Address | 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, Japan |
| Tel | +81-3-5630-9220 |
| uesaka.toshio@kao.com | |
| 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 | 株式会社TESホールディングス（東京都） |
| Other administrative information | |||||||
| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | Japanese Journal of Biometeorology, 56(2):89-99.2019 |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | Japanese Journal of Biometeorology, 56(2):89-99.2019 | ||||||
| Number of participants that the trial has enrolled | 24 | ||||||
| Results | A cold stress (water temperature of 15 degC , 1 min) test was performed on both hands of each subject 50 minutes after ingesting 270mg of CGA and placebo. SkT and SkBF were then measured simultaneously before and after the cold stress test. Significant improvement of the recovery of SkT and SkBF after the cold stress test were observed in CGA compared with placebo. These findings suggested that the ingestion of CGA improves SkT and SkBF after cold stress. |
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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 | Japanese Journal of Biometeorology, 56(2):89-99.2019 |
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| Participant flow | Japanese Journal of Biometeorology, 56(2):89-99.2019 |
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| Adverse events | Japanese Journal of Biometeorology, 56(2):89-99.2019 |
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| Outcome measures | Japanese Journal of Biometeorology, 56(2):89-99.2019 |
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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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| Date trial data considered complete |
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| Date analysis concluded |
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| 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=R000034404 |
