Unique ID issued by UMIN | UMIN000044608 |
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Receipt number | R000050950 |
Scientific Title | Examination of appetite suppression in healthy subjects by consumption of the test food: An open-label trial |
Date of disclosure of the study information | 2021/06/23 |
Last modified on | 2022/09/22 11:37:15 |
Examination of appetite suppression in healthy subjects by consumption of the test food
Examination of appetite suppression in healthy subjects by consumption of the test food
Examination of appetite suppression in healthy subjects by consumption of the test food: An open-label trial
Examination of appetite suppression in healthy subjects by consumption of the test food
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the suppression effect of appetite and weight loss in healthy subjects with consumption of the test food.
Efficacy
Confirmatory
Pragmatic
Not applicable
The measured values of body weight at 8 weeks after consumption (8w)
The measured values of the visual analogue scale (VAS) score (satiety, hunger, fullness, desire to eat richly flavored food, constipation, feeling refreshed during defecation, lightness of body, skin moisture, skin dullness, skin firmness and elasticity), nutrition-related items {weight, energy, moisture, protein, amino acid composition protein, fat, triglyceride (TG) equivalents, saturated fatty acids, monounsaturated fatty acids, polyunsaturated fatty acids, cholesterol, carbohydrates, available carbohydrates (monosaccharide equivalents), soluble dietary fiber, insoluble dietary fiber, total dietary fiber}, body mass index (BMI) and body fat percentage at 8w
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Duration: 8 weeks
Test food: Food containing basil seed
Administration: Take 2 g twice per day within 1 hour before lunch and dinner. Add about 150 mL of water into 1 packet (2 g), stir well and allow to swell before taking.
* If you forget to take the test food, take it as soon as you remember within the day.
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 20 years old or more
4. Healthy subjects
5. Subjects who are judged as eligible to participate in the study by the physician
6. Subjects whose BMI are between 25 kg/m2 or more and less than 30 kg/m2 at screening (Scr)
7. For subjects whose body weight are relatively heavy at Scr, taking account of the value of body fat percentage and the VAS score (satiety)
1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases
4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use
5. Subjects who are currently taking medications (including herbal medicines) and supplements, particularly taking antihypertensive drugs, anticoagulants and antiplatelet drugs in daily
6. Subjects who are allergic to medicines and/or the test food related products, particularly basil
7. Subjects who are scheduled for surgery during the consumption or within 2 weeks after the end of consumption
8. Subjects who are pregnant, breast-feeding, or planning to become pregnant after the agreement to participate in this trial
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial
10. Subjects who are judged as ineligible to participate in the study by the physician
10
1st name | Tsuyoshi |
Middle name | |
Last name | Takara |
Medical Corporation Seishinkai, Takara Clinic
Director
141-0022
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
03-5793-3623
t-takara@takara-clinic.com
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.
SHIRATORI Pharmaceutical Co., Ltd.
Profit organization
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi 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
IRB@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)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
2021 | Year | 06 | Month | 23 | Day |
Unpublished
11
Completed
2021 | Year | 06 | Month | 16 | Day |
2021 | Year | 06 | Month | 16 | Day |
2021 | Year | 06 | Month | 24 | Day |
2021 | Year | 11 | Month | 14 | Day |
2021 | Year | 06 | Month | 21 | Day |
2022 | Year | 09 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050950
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