Unique ID issued by UMIN | UMIN000044190 |
---|---|
Receipt number | 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 | 2022/11/18 16:07:10 |
Study for the Effects of a Test Food on Visceral Fat.
Study for the Effects of a Test Food on Visceral Fat.
Study for the Effects of a Test Food on Visceral Fat.
Study for the Effects of a Test Food on Visceral Fat.
Japan |
N/A(healthy adults)
Not applicable | Adult |
Others
NO
This study aims to examine efficacy of a test food on visceral fat.
Safety,Efficacy
Indexes for visceral fat and body fat.(1)
(1):Screening, Week 0, Week 1, Week 2.
*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).
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Placebo
3
Treatment
Food |
Intake of the test meal (3 times in a day; 2 weeks).
Intake of the test meal (3 times in a day; 2 weeks) and exercise (10 min. in a day; 2 weeks).
Intake of normal meals (keeping habit of eating before participating with the study; 2 weeks).
30 | years-old | <= |
65 | years-old | > |
Male
[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.
[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.
150
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.
Non-disclosure
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
i.takahashi@tes-h.co.jp
NO
2022 | Year | 05 | Month | 21 | Day |
Unpublished
Completed
2021 | Year | 04 | Month | 06 | Day |
2021 | Year | 04 | Month | 07 | Day |
2021 | Year | 06 | Month | 05 | Day |
2021 | Year | 07 | Month | 05 | Day |
2021 | Year | 05 | Month | 12 | Day |
2022 | Year | 11 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050300