Unique ID issued by UMIN | UMIN000034151 |
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Receipt number | R000038898 |
Scientific Title | Safety evaluation of the test food containing rose hip extract intake of 5 times more than regular daily intake in healthy subjects: a randomized, double-blind, placebo-controlled, parallel-group study |
Date of disclosure of the study information | 2018/09/14 |
Last modified on | 2019/03/31 13:47:34 |
Safety evaluation of the test food containing rose hip extract intake of 5 times more than regular daily intake in healthy subjects: a randomized, double-blind, placebo-controlled, parallel-group study
Safety evaluation of excessive intake of food containing rose hip extract in healthy subjects
Safety evaluation of the test food containing rose hip extract intake of 5 times more than regular daily intake in healthy subjects: a randomized, double-blind, placebo-controlled, parallel-group study
Safety evaluation of excessive intake of food containing rose hip extract in healthy subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To investigate the safety of consuming 5 times more than regular daily intake for 4 weeks in healthy Japanese subjects
Safety
Confirmatory
Pragmatic
Not applicable
1. Physical examination
2. Urinalysis
3. Blood test
4. Subjective symptoms (the Likert scale)
* Assess the measured value at screening (before consumption) and at 2 and 4 weeks after consumption and calculate the amount of change.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Prevention
Food |
Duration: 4 weeks
Test material: Tablet containing 100 mg of rose hip extract
Dose: 5 tablets per day
Administration: Chew five tablets after breakfast with water or lukewarm water, if necessary
* Daily dose should be taken within the day. If you forget to take the tablets, take them as soon as you remember within the day.
Duration: 4 weeks
Test material: Placebo tablet
Dose: 5 tablets per day
Administration: Chew five tablets after breakfast with water or lukewarm water, if necessary
* Daily dose should be taken within the day. If you forget to take the tablets, take them as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Healthy Japanese adult subjects
2. Subjects who are judged as eligible to participate in the study by the physician
3. Subjects who are between 18.5 kg/m2<= and <25 kg/m2 in BMI or between 25 kg/m2<= and <30 kg/m2 in BMI with <100 cm2 in the visceral fat area
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, glucose-6-phosphate dehydrogenase deficiency, sickle cell disease, hemochromatosis, thalassemia (Mediterranean anemia), or any other chronic diseases
4. Subjects who have disorder related to iron such as anemia
5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily
6. Subjects who are currently taking medications (including herbal medicines) and dietary supplements (health food)
7. Subjects who are an allergic reaction to medications and/or the test food related products
8. Subjects who are pregnant, breast-feeding, or planning to become pregnant
9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who work late-night shift and the life-styles are irregular
11. Subjects who are judged as ineligible to participate in the study by the physician
40
1st name | Kazuo |
Middle name | |
Last name | YAMAMOTO |
ORTHOMEDICO Inc.
CEO
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
kazu@orthomedico.jp
1st name | Naoko |
Middle name | |
Last name | SUZUKI |
ORTHOMEDICO Inc.
R&D Department
112-0002
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
03-3818-0610
nao@orthomedico.jp
ORTHOMEDICO Inc.
Morishita Jintan Co.,Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
03-5793-3623
info@takara-clinic.com
NO
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
2018 | Year | 09 | Month | 14 | Day |
Unpublished
44
Completed
2018 | Year | 09 | Month | 10 | Day |
2018 | Year | 09 | Month | 10 | Day |
2018 | Year | 09 | Month | 15 | Day |
2018 | Year | 12 | Month | 22 | Day |
2018 | Year | 09 | Month | 14 | Day |
2019 | Year | 03 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038898
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