UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042815 |
|---|---|
| Receipt number | R000048881 |
| Scientific Title | Effects of 1, 5-anhydro-D-fructose ingestion on arterial function |
| Date of disclosure of the study information | 2020/12/23 |
| Last modified on | 2023/09/05 19:07:46 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of 1, 5-anhydro-D-fructose ingestion on arterial function
Acronym
Effects of 1, 5-anhydro-D-fructose ingestion
Scientific Title
Effects of 1, 5-anhydro-D-fructose ingestion on arterial function
Scientific Title:Acronym
Effects of 1, 5-anhydro-D-fructose ingestion
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of single 1, 5-anhydro-D-fructose ingestion on arterial function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial stiffness (after 60-, 120-, and 180-min)
Flow-mediated dilation (after 60-, 120-, and 180-min)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Control-pure water (100 mL) and dextrin (1640 mg) ingestion
Single ingestion, Cross-over design of two conditions
Interventions/Control_2
Intervention-pure water (100 mL) and 1, 5-anhydro-D-fructose (1640 mg) ingestion
Single ingestion,Cross-over design of two conditions
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
18 years and older men and women, not restricted by a doctor from exercising, not have medication and smoking.
Key exclusion criteria
Have a cardiovascular and cerebrovascular diseases.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Nishiwaki |
Organization
Osaka Institute of Technology
Division name
Faculty of Engineering
Zip code
535-8585
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
TEL
06-6954-4391
masato.nishiwaki@oit.ac.jp
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Nishiwaki |
Organization
Osaka Institute of Technology
Division name
Faculty of Engineering
Zip code
535-8585
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
TEL
06-6954-4391
Homepage URL
masato.nishiwaki@oit.ac.jp
Sponsor or person
Institute
Faculty of Engineering, Osaka Institute of Technology
Institute
Department
Personal name
Funding Source
Organization
Yakuryo Kaihatsu 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
The Human Ethics Committee at the Osaka Insti tute of Technology
Address
5-16-1 Ohmiya, Asahi-ku, Osaka
Tel
06-4300-6883
Kenkyu@josho.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
大阪工業大学（大阪府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 23 | 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
15
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
| 2020 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048881
