UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019641 |
|---|---|
| Receipt number | R000022699 |
| Scientific Title | Effects of oxidative components on postprandial hyperglycemia and vascular function |
| Date of disclosure of the study information | 2015/11/05 |
| Last modified on | 2015/11/05 11:35:35 |
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Basic information
Public title
Effects of oxidative components on postprandial hyperglycemia and vascular function
Acronym
Effects of oxidative components on postprandial hyperglycemia and vascular function
Scientific Title
Effects of oxidative components on postprandial hyperglycemia and vascular function
Scientific Title:Acronym
Effects of oxidative components on postprandial hyperglycemia and vascular function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of oxidative components on postprandial blood glucose and vascular function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood samples were collected before ingestion and at 0.5, 1, 2, 3 and 4 hours after ingestion. FMD was measured before ingestion and at 1, 2, 3 and 4 hours after ingestion. Urine samples were collected before ingestion and accumulation urine samples were pooled during the postprandial periods for 4 hrs.
Primary outcomes are blood glucose and vascular endothelial function
Key secondary outcomes
Key secondary outcomes are insulin, d-ROMs and urinary 8-OHdG
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects ingested a single intake of the active meal, and ingested a single intake of the placebo meal after 7 days, and also ingested a single intake of the blank meal after 7 days.
Interventions/Control_2
The subjects ingested a single intake of the placebo meal, and ingested a single intake of the blank meal after 7 days, and also ingested a single intake of the active meal after 7 days.
Interventions/Control_3
The subjects ingested a single intake of the blank meal, and ingested a single intake of the active meal after 7 days, and also ingested a single intake of the placebo meal after 7 days.
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
| 25 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Subjects whose fasting blood glucose levels are ranged to less than 126mg/dl
2) Subjects whose HbA1c levels are ranged to less than 6.2%
3) Subjects whose BMI are from 18.5 kg/m2 to less than 30 kg/m2
4) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
1) Subjects who take continuous medical treatment
2) Subjects who are contracting heart disease, liver disease, kidney disease, digestive disease and allergy disease
3) Subjects with smoking habit
4) Subjects who participate in other clinical trials
5) Subjects who are not eligible due to physician`s judgment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Shimotoyodome |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-Machi, Haga-Gun, Tochigi, 321-3497, Japan
TEL
0285-68-7589
shimotoyodome.akira@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Jokura |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-Machi, Haga-Gun, Tochigi, 321-3497, Japan
TEL
0285-68-7164
Homepage URL
joukura.hiroko@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
花王株式会社生物科学研究所（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 05 | 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
| 2014 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2015 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022699
