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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 | UMIN000042007 |
Receipt No. | R000047942 |
Scientific Title | The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods in healthy adults with a higher fasting blood glucose level. |
Date of disclosure of the study information | 2020/10/05 |
Last modified on | 2020/12/03 |
Basic information | ||
Public title | Study of the blood glucose level reduction effects by ingestion of botanical extract-containing foods. | |
Acronym | Study of the blood glucose level reduction effects. | |
Scientific Title | The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods in healthy adults with a higher fasting blood glucose level. | |
Scientific Title:Acronym | The verification study to evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods. | |
Region |
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Condition | ||
Condition | Healthy Adult | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the reduction effects of blood glucose level by ingestion of botanical extract-containing foods. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Fasting blood glucose level |
Key secondary outcomes | Postprandial blood glucose level, Adiponectin, Weight, Uric acid, HbA1c |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Double blind -all involved are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | 12-week intake of the test food | |
Interventions/Control_2 | 12-week intake of the placebo food | |
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) Healthy males and females from 20 to 64 years of age
2) Fasting blood glucose level from 90 mg/dL to 125 mg/dL |
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Key exclusion criteria | 1) Subjects who have a habit of ingesting botanical extract-containing food.
2) Subjects having possibilities for emerging allergy related to the study. 3) Subjects who routinely take foods or medicines affecting the test result. 4) Subjects who have a disease requiring regular medication. 5) Subjects who are under treatment or have a history of serious disease (e.g. pancreatic disease, endocrine disease, liver disease, gastrectomy, kidney disease, heart disease or cancer). 6) Ineligible subjects with abnormal laboratory value or cardiopulmonary function. 7) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. 8) Subjects who have habits affecting research results, such as doing shift work day and night, or Subjects who have a plan that affect research results such as day and night shift work and overseas. 9) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. 10) Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. 11) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. 12) Subjects judged as unsuitable for the study by the investigator for other reasons. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | JAPAN TABLET CORPORATION | ||||||
Division name | Sales department | ||||||
Zip code | 611-0041 | ||||||
Address | 149-1, Megawa, Makishima-cho, Uji-shi, Kyoto | ||||||
TEL | 0774-20-5885 | ||||||
makoto-fujiwara@j-tab.com |
Public contact | |||||||
Name of contact person |
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Organization | TTC Co., Ltd. | ||||||
Division name | Clinical Research Planning Department | ||||||
Zip code | 150-0021 | ||||||
Address | Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo | ||||||
TEL | 03-5459-5329 | ||||||
Homepage URL | |||||||
k.ishida@ttc-tokyo.co.jp |
Sponsor | |
Institute | JAPAN TABLET CORPORATION |
Institute | |
Department |
Funding Source | |
Organization | Lion Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Medical Station Clinic Research Ethics Committee |
Address | 3-12-8, Takaban, Meguro-ku, Tokyo |
Tel | 03-6452-2712 |
saito876@eps.co.jp |
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 |
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 | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
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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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047942 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |