UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000024142 |
| Receipt No. | R000027753 |
| Scientific Title | Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14) |
| Date of disclosure of the study information | 2016/09/24 |
| Last modified on | 2020/01/07 (Ver. 7) |
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| Basic information | ||
| Public title | Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14) | |
| Acronym | Effect of the Drink Containing Plant Extract on Fat Metabolism | |
| Scientific Title | Effect of the Drink Containing Plant Extract on Fat Metabolism During Exercise (HR-2016-KO14) | |
| Scientific Title:Acronym | Effect of the Drink Containing Plant Extract on Fat Metabolism | |
| Region |
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| Condition | ||
| Condition | N/A(healthy adults) | |
| Classification by specialty |
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| Classification by malignancy | Others | |
| Genomic information | NO | |
| Objectives | |
| Narrative objectives1 | This study examines the effect of the drink containing plant extract on fat metabolism during exercise. |
| Basic objectives2 | Safety,Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | [1]Fat oxidation during exercise (test period I, test period II) |
| Key secondary outcomes | *Secondary outcomes
[1]Energy expenditure during exercise (screening, test period I, test period II) [2]Respiratory quotient during exercise (screening, test period I, test period II) [3]Fasting energy expenditure (screening, test period I, test period II) [4]Fasting fat oxidation (screening, test period I, test period II) [5]Fasting respiratory quotient (screening, test period I, test period II) [6]Blood examination (screening, test period I, test period II) [7]Urine analysis (screening, test period I, test period II) *Safety [1]Respiratory gas examination except indexes of primary and secondary outcomes (screening, test period I, test period II) [2]Blood examination (screening, test period I, test period II) [3]Urine analysis (screening, test period I, test period II) [4]Adverse event (each day during the test period) [5]Diagnosis by doctors (each day during the test period) |
| 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 | 2 | |
| Purpose of intervention | Treatment | |
| Type of intervention |
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| Interventions/Control_1 | [1]Oral intake of the test product (containing plant extract, 1 bottle in a day; 2 weeks)
[2]Observation [3]Washout (2 weeks) [4]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day; 2 weeks) [5]Observation |
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| Interventions/Control_2 | [1]Oral intake of the placebo product (not containing plant extract, 1 bottle in a day; 2 weeks)
[2]Observation [3]Washout (2 weeks) [4]Oral intake of the test product (containing plant extract, 1 bottle in a day; 2 weeks) [5]Observation |
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| 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 | Male | |||
| Key inclusion criteria | [1]Healthy males aged 20-49 years
[2]Individuals whose BMIs are over 20 and under 25 [3]Individuals who are healthy and have no disease [4]Individuals judged appropriate for the study by the principal [5]Individuals who can come to the designated venue for this study and be inspected [6]Individuals who are in the habit of walking or running and are capable of stopping these habits and conducting an exercise by ergometer [7]Individuals whose written informed consent have been obtained |
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| Key exclusion criteria | [1]Individuals using medical products
[2]Individuals who are sensitive to a test product [3]Individuals who will plan to go long term business trip or trip (more than 6 consecutive days) during test period [4]Individuals who are shift worker [5]Individuals who are difficult to participate due to have a liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases [6]Individuals with serious anemia [7]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30mg/day) [8]Individuals who are a smoker [9]Individuals who will be not capable of stopping to intake green tea, coffee and other beverage containing caffeine during the test period [10]Individuals who participated or will participate in other clinical studies [11]Individuals who have been medicated or operated in the past 2 months [12]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements (individuals who will stop to ingesting these foods at the begging of the test can participate into the study) [13]Individuals who have experience of bad feeling by blood sampling [14]Individuals who donated blood over 200mL in the past 1 month or have a plan to donate blood over 200mL. [15]Individuals who cannot intake test foods constantly during the test period [16]Individuals who cannot record a dietary record (for 6 days) [17]Individuals who deny to disclose past their own medical examination record [18]Individuals who cannot agree current informed consent [19]Individuals judged inappropriate for the study by the principal |
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| Target sample size | 22 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Medical Corporation Wakei-kai Medics Hongo Clinic | ||||||
| Division name | Director | ||||||
| Zip code | 113-0023 | ||||||
| Address | 2-2-6 Mukogaoka Bunkyo-ku Hongo Tokyo 113-0023, JAPAN | ||||||
| TEL | 03-6801-9761 | ||||||
| info@tes-h.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | TES Holdings Co. Ltd | ||||||
| Division name | Administrative Department of Clinical Trials | ||||||
| Zip code | 110-0013 | ||||||
| Address | 6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN | ||||||
| TEL | 03-6801-8480 | ||||||
| Homepage URL | |||||||
| info@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 | The Ethics Committee of the Oriental Ueno Detection Center |
| Address | Ueno Taito-ku Tokyo 110-0005, JAPAN |
| Tel | 03-5816-0711 |
| jimukyoku@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 | |
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| Date of disclosure of the study information |
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| Related information | |
| URL releasing protocol | N/A |
| Publication of results | Unpublished |
| Result | |||||||
| URL related to results and publications | N/A | ||||||
| Number of participants that the trial has enrolled | 22 | ||||||
| Results | There was no significant difference in the primary outcome. |
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| Results date posted |
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| Results Delayed | |||||||
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| Date of the first journal publication of results | |||||||
| Baseline Characteristics | Healthy males. |
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| Participant flow | 22 participants were enrolled in this study. One participant dropped out before starting to consume the test (or placebo) products. 21 participants who completed this study were incorporated into the analyses. |
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| Adverse events | No adverse events related to the test products were reported. |
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| Outcome measures | Fat oxidation during exercise. |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Date analysis concluded | |||||||
| Other | |
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| Management information | |||||||
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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=R000027753 |
