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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014167 |
Receipt No. | R000016500 |
Scientific Title | A randomized controlled trial to investigate whether "health beverage" improves obesity in human |
Date of disclosure of the study information | 2014/06/05 |
Last modified on | 2017/01/30 |
Basic information | ||
Public title | A randomized controlled trial to investigate whether "health beverage" improves obesity in human | |
Acronym | A RCT for the effect of "health beverage" on obesity in human | |
Scientific Title | A randomized controlled trial to investigate whether "health beverage" improves obesity in human | |
Scientific Title:Acronym | A RCT for the effect of "health beverage" on obesity in human | |
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 investigate the effect of "health beverage" on human obesity. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Computed Tomography
Total abdominal adipose tissue area Subcutaneous adipose tissue area Visceral adipose tissue area |
Key secondary outcomes | Height
Weight BMI Percent body fat Adiponectin Total cholesterol HDL cholesterol LDL cholesterol Triglyceride Free fatty acid |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Placebo |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | NO |
Concealment | No need to know |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Duration: 12 weeks
Test material: health beverage 180 ml Tree times/day (540 ml/day) |
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Interventions/Control_2 | Duration: 12 weeks
Test material: bottled water 500 ml One bottle per day (500 ml/day) |
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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 and Female | |||
Key inclusion criteria | a) Healthy adults, whose BMI are 25 or larger | |||
Key exclusion criteria | a)Persons who have previous medical history of malignancy, heart failure or myocardial infarction
b)Patients being treated for at least one of following diseases; atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, and other chronic disease c)Persons who take medicines, herbal medicines, or dietary supplements d)Persons who are allergic to medicines, or foods related to the test material of this trial e)Pregnant women, lactating women, or women who want to get pregnant during the trial period f)Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial g)Persons who are judged not suitable to participate in this trial by physician. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | ORTHOMEDICO, Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | |||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo. | ||||||
TEL | 03-3818-0610 | ||||||
kazu@orthomedico.jp |
Public contact | |||||||
Name of contact person |
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Organization | ORTHOMEDICO, Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | |||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | AKATSUKA Co., Ltd. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Seishin-kai Medical Association Inc, Takara Medical Clinic. |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 | 医療法人社団 盛心会 タカラクリニック (東京都)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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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=R000016500 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |