UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041622 |
|---|---|
| Receipt number | R000047062 |
| Scientific Title | Acute changes in arterial stiffness with palatinose versus sucrose intake in elderly |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/07/29 13:23:41 |
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Basic information
Public title
Acute changes in arterial stiffness with palatinose versus sucrose intake in elderly
Acronym
Acute changes in arterial stiffness with palatinose versus sucrose intake in elderly
Scientific Title
Acute changes in arterial stiffness with palatinose versus sucrose intake in elderly
Scientific Title:Acronym
Acute changes in arterial stiffness with palatinose versus sucrose intake in elderly
Region
| Japan |
Condition
Condition
Arteriosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to determine the acute effects of palatinose and sucrose intake on arterial stiffness in the middle-aged and elderly.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in aortic pulse wave velocity (PWV) and systemic PWV at baseline and 30, 60 and 90 minutes after ingestion of water (200 ml) containing 25 g of palatinose and sucrose.
Key secondary outcomes
Changes in Blood pressure, heart rate and blood glucose levels at baseline and 30, 60 and 90 minutes after ingestion of water (200 ml) containing 25 g of palatinose and sucrose.
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
25g palatinose (200ml) intake. Rest more than 7 days. 25g sucrose (200ml) intake.
Interventions/Control_2
25g sucrose (200ml) intake. Rest more than 7 days. 25g palatinose (200ml) intake.
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
| 45 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Schedule can be adjusted
2) Body mass index (BMI) is less than 18.5 to 25 kg/m2
3) You can follow the precautions when participating in the experiment
4) No smoking habits
5) 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) If you have a chronic disease
2) When the subject has severe physical symptoms and it is difficult to cooperate with the research
3) In addition, if the person in charge of the survey judges it inappropriate to participate
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Center for Fundamental Education
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
rkobayashi@ntu.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Kobayashi |
Organization
Teikyo University of Science
Division name
Center for Fundamental Education
Zip code
120-0045
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
TEL
03-6910-1010
Homepage URL
rkobayashi@ntu.ac.jp
Sponsor or person
Institute
Center for Fundamental Education, Teikyo University of Science
Institute
Department
Personal name
Funding Source
Organization
Research & Development Division, Mitsui Sugar 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
Teikyo University of Science
Address
2-2-1 Senju, Sakuragi, Adachi-ku, Tokyo, Japan
Tel
03-6910-1010
kenkyushien@ntu.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
帝京科学大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | 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
9
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 | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 31 | Day |
Last modified on
| 2021 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047062
