Unique ID issued by UMIN | UMIN000048012 |
---|---|
Receipt number | R000054725 |
Scientific Title | A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose: a randomized, placebo-controlled, double-blind, crossover comparison trial |
Date of disclosure of the study information | 2022/06/09 |
Last modified on | 2023/02/28 16:08:05 |
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose: a randomized, placebo-controlled, double-blind, crossover comparison trial
A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose
Japan |
Healthy Japanese subjects
Not applicable | Adult |
Others
NO
To verify the suppressive effect of the test food consumption on the elevation of postprandial blood glucose in healthy Japanese subjects
Efficacy
Confirmatory
Pragmatic
Not applicable
1. The incremental area under the curve (IAUC) of the postprandial blood glucose
1. The maximum blood concentration (Cmax) of the postprandial glucose
2. IAUC of insulin in the postprandial blood
3. The blood glucose and insulin before consumption of the test food and 30, 60, 90, and 120 minutes after carbohydrate load
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Placebo
Institution is not considered as adjustment factor.
2
Prevention
Food |
Period I: Capsule containing Siraitia grosvenorii extract (mogrol)
Period II: Placebo capsule
Carbohydrate load: "Sato No Gohan" (150 g; retort cooked rice)
After collecting blood samples prior to the ingestion of test foods, take one active or placebo capsules with water. Then, take the carbohydrate load within 10 minutes. Swallow carbohydrate load after chewing at least 30 times per a mouthful
*The intervention sequence is Period I to Period II, and each food is single ingestion.
*Washout period is for one week and more
Period I: Placebo capsule
Period II: Capsule containing Siraitia grosvenorii extract (mogrol)
Carbohydrate load: "Sato No Gohan" (150 g; retort cooked rice)
After collecting blood samples prior to the ingestion of test foods, take one active or placebo capsules with water. Then, take the carbohydrate load within 10 minutes. Swallow carbohydrate load after chewing at least 30 times per a mouthful
*The intervention sequence is Period I to Period II, and each food is single ingestion.
*Washout period is for one week and more
20 | years-old | <= |
Not applicable |
Male and Female
1. Japanese
2. Men or women
3. Subjects aged 20 or more
4. Healthy subjects
5. Subjects whose blood glucose levels are relatively high
6. Subjects whose IAUC of postprandial blood glucose are relatively large at screening (before consumption)
7. Subjects who are judged as eligible to participate in the study by the physician
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 who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any 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 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, lactation, or planning to become pregnant
8. Subjects who suffer from COVID-19
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
34
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.
Saraya 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)
2022 | Year | 06 | Month | 09 | Day |
Unpublished
36
Completed
2022 | Year | 05 | Month | 25 | Day |
2022 | Year | 05 | Month | 25 | Day |
2022 | Year | 06 | Month | 02 | Day |
2022 | Year | 12 | Month | 03 | Day |
2022 | Year | 06 | Month | 09 | Day |
2023 | Year | 02 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054725