UMIN-CTR Clinical Trial
| Recruitment status | Main results already published |
| Unique ID issued by UMIN | UMIN000018810 |
| Receipt No. | R000021422 |
| Scientific Title | Effects of ginger extract on energy metabolism |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2019/08/22 (Ver. 6) |
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| Basic information | ||
| Public title | Effects of ginger extract on energy metabolism | |
| Acronym | Effects of ginger extract on energy metabolism | |
| Scientific Title | Effects of ginger extract on energy metabolism | |
| Scientific Title:Acronym | Effects of ginger extract on energy metabolism | |
| Region |
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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 improve obesity by increasing energy metabolism through skeletal muscle hypermetabolism |
| Basic objectives2 | Efficacy |
| Basic objectives -Others | |
| Trial characteristics_1 | |
| Trial characteristics_2 | |
| Developmental phase | |
| Assessment | |
| Primary outcomes | Muscle energy metabolism related gene expression |
| Key secondary outcomes | Body weight |
| Base | |
| Study type | Interventional |
| Study design | |
| Basic design | Cross-over |
| Randomization | Randomized |
| Randomization unit | Individual |
| Blinding | Single blind -participants are blinded |
| Control | Placebo |
| Stratification | |
| Dynamic allocation | |
| Institution consideration | |
| Blocking | |
| Concealment | |
| Intervention | ||
| No. of arms | 2 | |
| Purpose of intervention | Prevention | |
| Type of intervention |
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| Interventions/Control_1 | Ginger extract-containing capsule
300 mg/day, 2 weeks |
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| Interventions/Control_2 | Placebo capsule | |
| 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 | Healthy adult males | |||
| Key exclusion criteria | 1. Subjects whose BMI is 30 or more, or less than 18.5
2. Subjects who take continuous medical treatment 3. Subjects suffering from serious disease |
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| Target sample size | 10 | |||
| Research contact person | |||||||
| Name of lead principal investigator |
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| Organization | Kao Corporation | ||||||
| Division name | Biological Science Research | ||||||
| Zip code | 3213497 | ||||||
| Address | 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi | ||||||
| TEL | 0285-68-7589 | ||||||
| shimotoyodome.akira@kao.co.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| Organization | Kao Corporation | ||||||
| Division name | Biological Science Research | ||||||
| Zip code | 3213497 | ||||||
| Address | 2606 Akabane, Ichikai-Machi, Haga-Gun, Tochigi | ||||||
| TEL | 0285-68-7643 | ||||||
| Homepage URL | |||||||
| misawa.koichi@kao.co.jp | |||||||
| Sponsor | |
| Institute | Kao Corporation |
| Institute | |
| Department | |
| Funding Source | |
| Organization | None |
| Organization | |
| Division | |
| Category of Funding Organization | Self funding |
| Nationality of Funding Organization | |
| Other related organizations | |
| Co-sponsor | |
| Name of secondary funder(s) | |
| IRB Contact (For public release) | |
| Organization | Human Research Ethics Committee of Biological Science Laboratories of Kao Corporation |
| Address | 2606, Akabane,Ichikai-Machi,Haga-Gun,Tochigi 321-3497,Japan |
| Tel | 0285-68-7589 |
| 304468@kao.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 | Unpublished due to the protocol including the intellectual property rights |
| Publication of results | Published |
| Result | |||||||
| URL related to results and publications | works in progress | ||||||
| Number of participants that the trial has enrolled | 10 | ||||||
| Results | 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 | Healthy men, 20 to 59 years old |
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| Participant flow | 10 participants completed and 10 subjects were incorporated into the analyses |
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| Adverse events | none |
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| Outcome measures | Changes in gene expression related to energy metabolism in skeletal muscle |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Main results already published | ||||||
| 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=R000021422 |
