Unique ID issued by UMIN | UMIN000051271 |
---|---|
Receipt number | R000058471 |
Scientific Title | A measurement study of blood components upon consumption of the test food: a randomized, double-blind, crossover comparison trial |
Date of disclosure of the study information | 2023/06/06 |
Last modified on | 2023/07/14 19:52:02 |
A measurement study of blood components upon consumption of the test food
A measurement study of blood components upon consumption of the test food
A measurement study of blood components upon consumption of the test food: a randomized, double-blind, crossover comparison trial
A measurement study of blood components upon consumption of the test food
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the change with time of astaxanthin compounds in blood upon consumption of the test food.
Bio-equivalence
Confirmatory
Pragmatic
Not applicable
The change of concentration of astaxanthin compounds in the blood
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Active
Institution is not considered as adjustment factor.
YES
2
Prevention
Food |
<Duration>
Single ingestion (two times)
<Test food>
Period I: Capsule containing Haematococcus algal extract (capsule form), sports drink (liquid form)
Period II: Emulsified astaxanthin formulation (liquid form), placebo capsule (capsule form)
<Prescribed food>
Jelly drink
<Administration>
After the measurements before consumption of the test food, take in the order, the capsule form and liquid form test foods, and then the prescribed food (jelly drink). Take the test foods and the prescribed food within 15 minutes.
500 mL of water is provided at the time of consumption of the test foods and the prescribed food, and can be drunk as necessary. The 500 mL of water should be finished before the blood collection at eight hours after consumption on each day of ingestion.
*The intervention sequence is Period I to Period II
*Washout period is one week or more
<Duration>
Single ingestion (two times)
<Test food>
Period I: Emulsified astaxanthin formulation (liquid form), placebo capsule (capsule form)
Period II: Capsule containing Haematococcus algal extract (capsule form), sports drink (liquid form)
<Prescribed food>
Jelly drink
<Administration>
After the measurements before consumption of the test food, take in the order, the capsule form and liquid form test foods, and then the prescribed food (jelly drink). Take the test foods and the prescribed food within 15 minutes.
500 mL of water is provided at the time of consumption of the test foods and the prescribed food, and can be drunk as necessary. The 500 mL of water should be finished before the blood collection at eight hours after consumption on each day of ingestion.
*The intervention sequence is Period I to Period II
*Washout period is one week or more
18 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
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 who are pregnant, lactating, or planning to become pregnant during this trial
8. 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
9. Subjects who are judged as ineligible to participate in this study by the physician
4
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.
Fuji Chemical Industries 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 Bldg., 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 | 06 | Month | 06 | Day |
Unpublished
4
No longer recruiting
2023 | Year | 05 | Month | 24 | Day |
2023 | Year | 05 | Month | 24 | Day |
2023 | Year | 06 | Month | 06 | Day |
2023 | Year | 07 | Month | 30 | Day |
2023 | Year | 06 | Month | 06 | Day |
2023 | Year | 07 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058471
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