UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039942 |
|---|---|
| Receipt number | R000045545 |
| Scientific Title | Investigation on the facts of postprandial hyperglycemia boundary type and health literacy of female college students |
| Date of disclosure of the study information | 2020/03/25 |
| Last modified on | 2021/04/15 08:59:13 |
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Basic information
Public title
Investigation on the facts of postprandial hyperglycemia boundary type and health literacy of female college students
Acronym
Investigation on the facts of postprandial hyperglycemia boundary type and health literacy of female college students
Scientific Title
Investigation on the facts of postprandial hyperglycemia boundary type and health literacy of female college students
Scientific Title:Acronym
Investigation on the facts of postprandial hyperglycemia boundary type and health literacy of female college students
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the facts of postprandial hyperglycemia boundary type and health literacy of the students of the training course of registered dietitians
Basic objectives2
Others
Basic objectives -Others
Investigate the facts of postprandial hyperglycemia boundary type and health literacy by observational research
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood glucose levels (fasting blood glucose level before glucose load and blood glucose level at 120 minutes after glucose load)
Key secondary outcomes
1. Physical examination (body height, weight, BMI, body fat percentage, lean body mass, systolic and diastolic blood pressure)
2. Questionnaire (exercise habits per week, average exercise length on the day of exercise, exercise history, personal medical history of diabetes mellitus, family medical history of diabetes mellitus)
3. The healthy eating literacy scale
4. Dietary survey (Calorie and Nutrition Diary; CAND)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Adult subjects who are sophomore, junior, or senior of the department of health and nutrition, Wayo Women's University
Key exclusion criteria
1. Subjects who are under age
2. Subjects who have a medical history of diabetes mellitus
3. Subjects whose fasting blood glucose levels are >= 126 mg/dL
4. Subjects who are undergoing medical treatment and taking medications
5. Subjects who are currently taking medications, "Foods for Specified Health Uses", or other health foods having the possibility of any effects on the result of the study
6. Subjects who are intending to become pregnant during this trial, being pregnant (including possibilities), or lactating
7. Subjects who are judged by the principal investigator as ineligible to participate in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
director
Zip code
141-0022
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Moto |
Organization
Wayo Women's University
Division name
Department of health and nutrition
Zip code
272-8533
Address
2-3-1 Konodai, Ichikawa-shi, Chiba, Japan
TEL
047-371-2393
Homepage URL
moto@wayo.ac.jp
Sponsor or person
Institute
Department of health and nutrition, Wayo Women's University
Institute
Department
Personal name
Funding Source
Organization
ORTHOMEDICO Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Integrated institute for regulatory science, Research organization for Nano & Life Innovation, Waseda University
Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takara Clinic Certified Review Board
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
CRB@takara-clinic.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1030190266
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
和洋女子大学 (千葉県)
Wayo Women's University (Chiba, Japan)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 25 | 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
122
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
| 2020 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing else
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2021 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045545
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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