UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037823 |
|---|---|
| Receipt number | R000043121 |
| Scientific Title | A randomized, single blind, placebo-controlled comparison group study to investigate the effect of low carbohydrate cake on the change of postprandial blood glucose level. |
| Date of disclosure of the study information | 2019/08/28 |
| Last modified on | 2021/01/18 11:47:33 |
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Basic information
Public title
A randomized, single blind, placebo-controlled comparison group study to investigate the effect of low carbohydrate cake on the change of postprandial blood glucose level.
Acronym
Clinical trial to investigate the effect of low carbohydrate cake on the change of postprandial blood glucose level.
Scientific Title
A randomized, single blind, placebo-controlled comparison group study to investigate the effect of low carbohydrate cake on the change of postprandial blood glucose level.
Scientific Title:Acronym
Clinical trial to investigate the effect of low carbohydrate cake on the change of postprandial blood glucose level.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of low carbohydrate cake on the change of postprandial glucose level.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The blood glucose level at 60 minutes after taking the test food or placebo food.
Key secondary outcomes
1. The actual values and the changes of blood glucose level at at baseline, 30min,60min,90min and 120minutes after taking the test food or placebo food.
2.The incremental area under the curve of the postprandial blood glucose and insulin. The maximum levels of the postprandial blood glucose and insulin.
3.The actual values and the changes of triglyceride and free fatty acid at each evaluation point after the intervention of the cakes.
4. The incremental area under the curve and the maximum level of triglyceride and free fatty acid.
5.The actual values and the change of glycolipid metabolism related index at each evaluation point except from one to four (RLP-C, ApoB48, insulin, active GLP-1).
6.The correct answer rate that the examination food is test food or not.
7. Satisfaction of the cake as test food or placebo food.
8.Adverse events.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects take one test food (low carbohydrate cake).
Interventions/Control_2
The subjects take one placebo food (normal carbohydrate cake).
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who have no abnormality in clinical problems by screening tests.
3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study
Key exclusion criteria
1.Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine,
cardiovascular and/or mental disease, or
who have history of those disease.
2.Subjects who had a serious injury or surgical history within 12 weeks prior to this study.
3.Pre-or post-menopausal women having obvious changes in physical condition.
4.Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
5.Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 20g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence.
6.Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
7.Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study.
8.Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study.
9.Subjects who have cognitive disorder or who have possibility of the disorder.
10.Subjects who participated and took the study drug in other clinical trials within four weeks prior to this study.
11.Subjects who are judges as unsuitable for this study by the principal invesetigator or subinvestigators.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, University of Miyazaki hospital
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuji |
| Middle name | |
| Last name | Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, University of Miyazaki hospita
Zip code
889-1692
Address
Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
University of Miyazaki
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Miyazaki Diabetes Prevention Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of University of Miyazaki
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel
0985-85-9010
igakubu_kenkyu@med.miyazaki-u.ac.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
宮崎大学医学部附属病院（宮崎県）University of Miyazaki hospital：Miyazaki prefecture
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 28 | 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
| 2019 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 12 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 01 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 27 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043121
