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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000044190 |
Receipt No. | R000050300 |
Scientific Title | Study for the Effects of a Test Food on Visceral Fat. |
Date of disclosure of the study information | 2022/05/21 |
Last modified on | 2021/08/31 |
Basic information | ||
Public title | Study for the Effects of a Test Food on Visceral Fat. | |
Acronym | Study for the Effects of a Test Food on Visceral Fat. | |
Scientific Title | Study for the Effects of a Test Food on Visceral Fat. | |
Scientific Title:Acronym | Study for the Effects of a Test Food on Visceral Fat. | |
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 aims to examine efficacy of a test food on visceral fat. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Indexes for visceral fat and body fat.(1)
(1):Screening, Week 0, Week 1, Week 2. |
Key secondary outcomes | *Secondary indexes
[1]Specific blood test(1). [2]Specific saliva test(2). [3]Specific fecal test(2). [4]QOL(2). [5]Specific exhalation test(2). *Safety [1]Blood pressure, pulsation(1). [2]Hematologic test(1). [3]Blood biochemical test(1). [4]Urine analysis(1). [5]Bone density measurement(2). [6]Subject's diary(3). [7]Doctor's questions(1). [8]Side effects and adverse events(2). (1):Screening, Week 0, Week 1, Week 2. (2):Week 0, Week 1, Week 2. (3): Everyday From the seven days before the first day of ingestion of a test material to the last day of the test. *Other indexes Dietary survey (4) (4):Week 0 (for 3 days), Week 2 (for 3 days). |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 3 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Intake of the test meal (3 times in a day; 2 weeks). | |
Interventions/Control_2 | Intake of the test meal (3 times in a day; 2 weeks) and exercise (10 min. in a day; 2 weeks). | |
Interventions/Control_3 | Intake of normal meals (keeping habit of eating before participating with the study; 2 weeks). | |
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 Japanese males aged 30-64 years.
[2] Individuals whose BMI is not less than 23 kg/m2 and under 30 kg/m2 and visceral fat level is relatively high. [3]Individuals whose written informed consent has been obtained. [4]Individuals who can visit an inspection facility and be inspected in designated days. [5]Individuals judged appropriate for the study by the principal. |
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Key exclusion criteria | [1]Individuals who cannot continue to eat a test meal for 2 weeks.
[2]Individuals who are in constipation. [3]Individuals using medical products. [4]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [5]Individuals who used or applied a drug for treatment of disease in the past 1 month. [6]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease. [7]Individuals who contract or have a history of serious endocrine disease. [8]Individuals who recorded weight gain and loss (+-2 kg) in the past 3 months. [9]Individuals who have a plan to take health checkup from 2 weeks before Week 0 to the last day of the test. [10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [11]Individuals who are sensitive to test product or other foods, and medical products. [12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 30g/day). [13]Individuals who smoke over 21 cigarettes in a day. [14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [15]Individuals who have a habit to use drug claiming to reduce visceral fat and body fat in the past 3 months. [16]Individuals who participated in other clinical studies in the past 3 months. [17]Individuals who are or whose family is engaged in health foods of functional foods. [18]Individuals judged inappropriate for the study by the principal. |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Ueno-Asagao Clinic | ||||||
Division name | Head | ||||||
Zip code | 110-0015 | ||||||
Address | 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN | ||||||
TEL | +81-3-6240-1162 | ||||||
info@ueno-asagao.clinc |
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 | 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, 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 | Non-disclosure |
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 | Ueno-Asagao Clinic Ethical Review Committee |
Address | 6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN |
Tel | +81-3-6240-1162 |
i.takahashi@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 | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050300 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |