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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000047768 |
Receipt No. | R000054458 |
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 | 2022/05/16 |
Last modified on | 2022/06/23 |
Basic information | ||
Public title | A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose | |
Acronym | A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose | |
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 | |
Scientific Title:Acronym | A verification study of the suppressive effect of the test food consumption on the elevation of postprandial blood glucose | |
Region |
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Condition | |||
Condition | Healthy Japanese subjects | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To verify the effect of consumption of the test food on postprandial blood glucose in healthy Japanese subjects |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | 1. The incremental area under the curve (IAUC) of the postprandial blood glucose |
Key secondary outcomes | 1. The maximum blood concentration (Cmax) of the postprandial blood glucose
2. The blood glucose level before consumption of the test food, at 30, 60, 90, and 120 minutes after consumption of the test food |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | Institution is not considered as adjustment factor. |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Period I: Sennen no aojiru
Period II: Placebo Carbohydrate load: Trelan-G 50 g After taking blood samples prior to the ingestion of test foods, take one pack of the test food or placebo with approximately 200 mL of water. After 10 minutes, take the carbohydrate load within 5~10 minutes. *The intervention sequence is Period I to Period II, and each food is single ingestion. *Washout period is for one week and more |
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Interventions/Control_2 | Period I: Placebo
Period II: Sennen no aojiru Carbohydrate load: Trelan-G 50 g After taking blood samples prior to the ingestion of test foods, take one pack of the test food or placebo with approximately 200 mL of water. After 10 minutes, take the carbohydrate load within 5~10 minutes. *The intervention sequence is Period I to Period II, and each food is single ingestion. *Washout period is for one week and more |
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Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1. Japanese
2. Men or women 3. Subjects aged 20 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects whose IAUC of postprandial blood glucose are relatively large at screening (before consumption) |
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Key exclusion criteria | 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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Corporation Seishinkai, Takara Clinic | ||||||
Division name | Director | ||||||
Zip code | 141-0022 | ||||||
Address | 9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan | ||||||
TEL | 03-5793-3623 | ||||||
t-takara@takara-clinic.com |
Public contact | |||||||
Name of contact person |
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Organization | ORTHOMEDICO Inc. | ||||||
Division name | R&D Department | ||||||
Zip code | 112-0002 | ||||||
Address | 2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan. | ||||||
TEL | 03-3818-0610 | ||||||
Homepage URL | |||||||
nao@orthomedico.jp |
Sponsor | |
Institute | ORTHOMEDICO Inc. |
Institute | |
Department |
Funding Source | |
Organization | ENICIA Inc. |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | the ethical committee of the Takara Clinic, Medical Corporation Seishinkai |
Address | 9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan. |
Tel | 03-5793-3623 |
IRB@takara-clinic.com |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 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) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 10 |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054458 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |