Unique ID issued by UMIN | UMIN000039954 |
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Receipt number | R000045285 |
Scientific Title | Effects of a Test Food for Reducing Body Fat. |
Date of disclosure of the study information | 2020/03/27 |
Last modified on | 2021/03/29 21:45:15 |
Effects of a Test Food for Reducing Body Fat.
Effects of a Test Food for Reducing Body Fat.
Effects of a Test Food for Reducing Body Fat.
Effects of a Test Food for Reducing Body Fat.
Japan |
N/A (healthy adults)
Not applicable | Adult |
Others
NO
This study examines effects and safety of a test food for reducing body fat.
Safety,Efficacy
[1]Changes of visceral fat area measured by FatScan software on a CT image (Week 0, Week 12).
*Secondary indexes
[1]Changes of subcutaneous fat area and total fat area measured by FatScan software on a CT image (Week 0, Week 12).
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 8, Week 12).
[3]Waist girth, hip girth / waist-hip ratio (Screening, Week 0, Week 4, Week 8, Week 12).
*Safety
[1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 8, Week 12).
[2]Hematologic test (Screening, Week 0, Week 4, Week 8, Week 12).
[3]Blood biochemical test (Screening, Week 0, Week 4, Week 8, Week 12).
[4]Urine analysis (Screening, Week 0, Week 4, Week 8, Week 12).
[5]Doctor's questions (Screening, Week 0, Week 4, Week 8, Week 12).
[6]Subject's diary (From the first day of ingestion of a test material to the last day of the test).
*Other indexes
[1]Evaluation of abdominal fat by impedance method (Screening).
[2]Dietary survey (3 days prior to each inspection date).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Oral intake of the test food (6 pills in a day; 12 weeks).
Oral intake of the placebo food (6 pills in a day; 12 weeks).
35 | years-old | <= |
65 | years-old | > |
Male and Female
[1]Healthy Japanese males and females aged 35-64 years.
[2]Individuals whose BMI is not less than 23 kg/m2 and under 30 kg/m2.
[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.
[1]Individuals using medical products.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[5]Individuals who are a patient or have a history of or endocrine disease.
[6]Individuals who have gained or lost 2 kg of body weight in the past 3 months.
[7]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[8]Individuals who are sensitive to test product or other foods, and medical products.
[9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[10]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[11]Individuals having a habit to intake a food containing same components with the test food in the past 3 months.
[12]Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months.
[13]Individuals who are or are possibly, or are lactating.
[14]Individuals who participated in other clinical studies in the past 3 months.
[15]Individuals who are or whose family is engaged in health foods of functional foods.
[16]Individuals judged inappropriate for the study by the principal.
80
1st name | Takahiro |
Middle name | |
Last name | Ono |
Ueno-Asagao Clinic
Head
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
info@ueno-asagao.clinc
1st name | Ryoma |
Middle name | |
Last name | Shimizu |
TES Holdings Co., Ltd.
Administrative Department of Clinical Trials
110-0015
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6801-8480
r.shimizu@tes-h.co.jp
TES Holdings co., Ltd.
Kobayashi Pharmaceutical Co., Ltd.
Profit organization
Ueno-Asagao Clinic Ethical Review Committee
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
+81-3-6240-1162
jimukyoku@tes-h.co.jp
NO
2020 | Year | 03 | Month | 27 | Day |
Unpublished
80
Completed
2020 | Year | 02 | Month | 18 | Day |
2020 | Year | 02 | Month | 19 | Day |
2020 | Year | 07 | Month | 13 | Day |
2020 | Year | 10 | Month | 11 | Day |
2020 | Year | 03 | Month | 26 | Day |
2021 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045285
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