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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041622
Receipt No. 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 2021/03/05

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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
Email 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
Email rkobayashi@ntu.ac.jp

Sponsor
Institute Center for Fundamental Education, Teikyo University of Science
Institute
Department

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
Email 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 No longer recruiting
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 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047062

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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