Unique ID issued by UMIN | UMIN000049108 |
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Receipt number | R000055947 |
Scientific Title | Effects of consumption of the test food on appetite in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
Date of disclosure of the study information | 2023/12/20 |
Last modified on | 2023/03/29 17:14:56 |
Effects of consumption of the test food on appetite in healthy Japanese subjects
Effects of consumption of the test food on appetite in healthy Japanese subjects
Effects of consumption of the test food on appetite in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Effects of consumption of the test food on appetite in healthy Japanese subjects
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the effects of consumption of the test food on appetite in healthy Japanese subjects
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
1. The feeling of hunger and prospective food consumption measured by visual analogue scale (VAS) at two weeks after consumption (2w)
2. The feeling of hunger and prospective food consumption measured by VAS at pre-consumption examination (single ingestion; 0w)
1. Appetite survey
2. The subjective diet-related quality of life (SDQOL)
3. MOS Short-Form 36-Item Health. Survey (SF-36v2)
4. Blood markers
5. Body composition
6. Nutrition survey
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
Institution is not considered as adjustment factor.
YES
2
Treatment
Food |
Duration: Two weeks
Take one active tablet with a drink such as water once daily.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
Duration: Two weeks
Take one placebo tablet with a drink such as water once daily.
*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.
40 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults aged 40 or more
4. Healthy subjects
5. Subjects whose the feeling of hunger measured by VAS is relatively low
6. Subjects whose BMI is 18.5 kg/m2 or more and less than 25 kg/m2
7. Subjects who have given written informed consent to participate in this trial
8. Subjects who do not have an exercise habit
1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Subjects currently undergoing treatment for any of the following chronic diseases:
cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily
5. Subjects who are currently taking medications (including herbal medicines) and supplements
6. Subjects who are allergic to medicines and/or the test food related products
7. Subjects whose score of the Council of Nutrition Appetite Questionnaire (CNAQ-J) is 16 or less
8. Subjects whose BMI has increased or decreased by 10% or more within the last three months
9. Subjects who work in the late-night shift or in shifts at least once weekly
10. Subjects who work with driving vehicles or operating machinery accompany by danger
11. Subjects who are pregnant, lactating, or planning to become pregnant during this trial
12. Subjects who suffer from COVID-19
13. 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
14. Subjects who are judged as ineligible to participate in this study by the physician
42
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.
KAMEDA SEIKA 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)
2023 | Year | 12 | Month | 20 | Day |
Unpublished
46
Completed
2022 | Year | 09 | Month | 14 | Day |
2022 | Year | 09 | Month | 14 | Day |
2022 | Year | 10 | Month | 04 | Day |
2022 | Year | 12 | Month | 21 | Day |
2022 | Year | 10 | Month | 04 | Day |
2023 | Year | 03 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055947
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