UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045001 |
|---|---|
| Receipt number | R000051408 |
| Scientific Title | Effect of 12-week Palatinose Intake on Arterial Stiffness in Middle-aged and Elderly People |
| Date of disclosure of the study information | 2021/08/05 |
| Last modified on | 2022/07/29 10:21:05 |
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Basic information
Public title
Effect of 12-week Palatinose Intake on Arterial Stiffness in Middle-aged and Elderly People
Acronym
Effect of 12-week Palatinose Intake on Arterial Stiffness in Middle-aged and Elderly People
Scientific Title
Effect of 12-week Palatinose Intake on Arterial Stiffness in Middle-aged and Elderly People
Scientific Title:Acronym
Effect of 12-week Palatinose Intake on Arterial Stiffness in Middle-aged and Elderly People
Region
| Japan |
Condition
Condition
Arteriosclerosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the chronic effects of palatinose intake on arterial stiffness in middle-aged and elderly Japanese men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sixty subjects will be randomly divided by a random number table into two groups: 30 subjects in the test food (palatinose) intake group and 30 subjects in the control food (sucrose) intake group (randomized controlled trial). Subjects will come to the measurement room to measure their height, weight, body fat percentage, and body mass index before (before the intervention), 4, 8, and 12 weeks after (total of 4 visits) the intake of 25g of the test or control food per day, and after 9:00 pm on the night before the measurement, with no intake other than water and empty stomach on the day of the measurement (early morning fasting). Then, systemic arterial, proximal aortic, and aortic stiffness, brachial and ankle arterial blood pressure, heart rate, blood glucose level, blood insulin concentration, and endothelin-1 (vasoconstrictor) will be evaluated before and 60 and 120 minutes after oral intake of the 75g glucose tolerance test carbohydrate solution.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Sixty subjects were randomly divided into 30 test food (palatinose) intake groups using a random number table (randomized controlled trial).
Interventions/Control_2
Sixty subjects were randomly divided into 30 control food (sucrose) intake groups using a random number table (randomized controlled trial).
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Those who can adjust their schedule
2) Body mass index between 18.5 and less than 25 kg/m2
3) Those who can follow the precautions for participation in the experiment
4) No smoking habit in the past
5) Those who have not been diagnosed with any abnormality in blood test, urine test, chest X-ray, electrocardiogram, etc. in a medical examination within one year
6) Those who prefer jelly and consume it regularly
Key exclusion criteria
(1) Subjects with chronic diseases (cardiovascular diseases, cardiovascular complications, diabetes: fasting blood glucose level of 126 mg/dl or higher, blood glucose level of 200 mg/dl or higher at any time, 75gOGTT 2-hour blood glucose level of 200 mg/dl or higher, hypertension: 140/90 mmHg or higher, hyperlipidemia: LDL 120-139 mg/dl or higher, HDL less than 40 mg/dl, triglycerides 150 mg/dl or higher, etc.) after checking the health certificate.
(2) If the subject has serious physical symptoms that make it difficult to cooperate in the study.
(3) Subjects who have experienced fainting due to vasovagal reflex during injection or intravenous infusion.
(4) Those who have experienced chest pain during exertion or at rest.
(5) Patients with pacemakers or other implantable medical devices
(5) Those who are using an implanted medical device such as a pacemaker (6) Other cases in which the investigator judges that participation in the survey is inappropriate
(7) Those who are not taking any medication or supplements.
(8) Those who do not exercise regularly.
(9) Those who have not had a medical checkup within one year.
(10) Those who cannot be confirmed to be normal after undergoing a medical examination that lacks items such as blood test, urine test, chest X-ray, and electrocardiogram in the medical examination mentioned in the participation criteria (4).
Target sample size
60
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
| 2021 | Year | 08 | 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
53
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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | 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=R000051408
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| Registered date | File name |
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