UMIN-CTR Clinical Trial

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