UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000046715 |
|---|---|
| Receipt number | R000053289 |
| Scientific Title | The study for the suppressive effect on the elevation of postprandial blood glucose level by intake of the food containing seaweed |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2023/08/08 14:41:46 |
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Basic information
Public title
The study for the suppressive effect on the elevation of postprandial blood glucose level by intake of the food containing seaweed
Acronym
The study for the suppressive effect on the elevation of postprandial blood glucose level by intake of the food containing seaweed
Scientific Title
The study for the suppressive effect on the elevation of postprandial blood glucose level by intake of the food containing seaweed
Scientific Title:Acronym
The study for the suppressive effect on the elevation of postprandial blood glucose level by intake of the food containing seaweed
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the suppressive effect on the elevation of postprandial blood glucose level by intake of the food containing seaweed
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose level (AUC)
Key secondary outcomes
Postprandial blood glucose levels, Postprandial maximum blood glucose levels, Postprandial blood insulin level, Incremental area under the curve of blood glucose level (iAUC)
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
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food (single ingestion) - washing out (about 1 week) - intake of placebo (single ingestion)
Interventions/Control_2
Intake of placebo (single ingestion) - washing out (about 1 week) - intake of test food (single ingestion)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 65 years of age.
(2) Fasting blood glucose level is 95 mg / dL or more and less than 126 mg / dL on preliminary examination.
Key exclusion criteria
(1) Subjects who are judged as unsuitable for the study based on the results of clinical laboratory test or cardiopulmonary function.
(2) Subjects who routinely use medicines and health foods related to blood glucose level and glucose metabolism.
(3) Subjects who have possibilities for emerging allergy related to the study.
(4) Subjects who have under treatment (including followup).
(5) Subjects who have a history of pancreatic disease, endocrine disease (including diseases related to the thyroid gland), liver disease, gastric resection and other diseases that may cause diabetes / glucose metabolism disorders.
(6) Subjects who have a disease requiring continuous medication, or serious medical history who needed medication.
(7) Subjects whose clinical laboratory tests, blood pressure, and physical measurements on preliminary examination are significantly out of the standard values.
(8) Subjects who have a habit of skipping food on a daily basis, or those who have an extremely irregular diet.
(9) Subjects who are engaged in day / night shift work, midnight work, or irregular life habits.
(10) Subjects who have been diagnosed with insomnia or sleep apnea, or who have extremely irregular sleep habits.
(11) Subjects who have a habit of drinking alcohol more than 5 days in a week.
(12) Subjects who have a habit of smoking.
(13) Subjects who cannot take the meals provided during the study period or those who cannot take the curry and cooked rice in a completely mixed form.
(14) Subjects who plan to travel abroad or domestically for more than a week during the study.
(15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire.
(16) Subjects who have participated in other clinical study within the last one month prior to the current study or have participated in other clinical studies.
(17) Subjects who intend to become pregnant or lactating.
(18) Subjects who are judged as unsuitable for the study by the investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Iwasa |
Organization
RIKEN VITAMIN Co., Ltd.
Division name
Planning & Development Department (Food Products)
Zip code
160-0004
Address
1-6-1Yotsuya, Shinjuku-ku, Tokyo
TEL
03-5362-1329
yas_iwasa@rike-vita.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Miyayama |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Trial Planning Section
Zip code
162-0822
Address
2-23, Shimomiyabi-cho, Shinjuku-ku, Tokyo
TEL
070-3023-8210
Homepage URL
miyayama.saki392@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
RIKEN VITAMIN Co., Ltd.
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, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@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
| 2023 | Year | 03 | Month | 15 | Day |
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 24 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053289
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