UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053308 |
|---|---|
| Receipt number | R000060838 |
| Scientific Title | Verification on the effects of beverage intake on vascular endothelial function and postprandial energy metabolism in healthy subjects. |
| Date of disclosure of the study information | 2024/01/23 |
| Last modified on | 2024/01/10 14:30:13 |
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Basic information
Public title
Verification on the effects of beverage intake on vascular endothelial function and postprandial energy metabolism in healthy subjects.
Acronym
Verification on the effects of beverage intake on vascular endothelial function and postprandial energy metabolism in healthy subjects.
Scientific Title
Verification on the effects of beverage intake on vascular endothelial function and postprandial energy metabolism in healthy subjects.
Scientific Title:Acronym
Verification on the effects of beverage intake on vascular endothelial function and postprandial energy metabolism in healthy subjects.
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the function of beverage intake intervention in healthy adults aged 40-65 years to maintain and improve vascular endothelial function and energy metabolism, which are impaired by aging and obesity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fat Oxidation
Key secondary outcomes
Energy expenditure, carbohydrate oxidation, respiratory quotient, FMD, body weight, body fat, and bodily sensation value
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Intake of active food for 4 weeks - Washout period (4 weeks) - Intake of placebo food for 4 weeks
Interventions/Control_2
Intake of placebo food for 4 weeks - Washout period (4 weeks) - Intake of active food for 4 weeks
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Male and female subjects between 40 and 65 years of age at the time consent is obtained.
2) Subjects who are healthy and free from chronic diseases.
3) Subjects who are with a BMI of at least 22 and less than 30 kg/m2 and who are not obese.
4) Subjects who exercise less than once a week.
5) Subjects who have received a thorough explanation of their participation in this study, and who have given their free and voluntary written consent based on a thorough understanding of the study.
Key exclusion criteria
1) Subjects who have any disease and are being treated with medication.
2) Subjects who are obese (BMI of 25 kg/m2 or more and any of the following 1 through 12).
1.Abdominal circumference Male 85 cm or more, Female 90 cm or more
2.Have been diagnosed with impaired glucose tolerance (type 2 diabetes, impaired glucose tolerance)
3.Have been diagnosed with dyslipidemia
4.Have been diagnosed with hypertension
5.Have been diagnosed with hyperuricemia or gout
6.Have been diagnosed with coronary artery disease, myocardial infarction, or angina pectoris
7.Has been diagnosed with cerebral infarction, cerebral thrombosis, or transient ischemic attack (TIA)
8.Fatty liver (ever diagnosed with non-alcoholic fatty liver disease (NAFLD))
9.Menstrual abnormalities, infertility
10.Have been diagnosed with sleep apnea syndrome (SAS), obesity hypoventilation syndrome
11.Have been diagnosed with musculoskeletal disease, osteoarthritis (knee, hip), osteoarthritis of the spine, osteoarthritis of the fingers
12.Have been diagnosed with obesity-related kidney disease
3) Subjects who suffering from serious or allergic diseases.
4) Subjects who regularly use dietary supplements or other health foods during the study period.
5) Subjects who consume excessive amounts of purple (anthocyanin-containing) foods.
6) Heavy drinkers of alcohol.
7) Smokers.
8) Subjects who live day and night in reverse (night shift, etc.).
9) Subjects who exercise more than twice a week.
10) Subjects who plan to make significant changes in their exercise habits or lifestyle, such as work or study, during the study period.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | tohru |
| Middle name | |
| Last name | minamino |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Cardiovascular Biology and Medicine
Zip code
113-8421
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
t.minamino@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Matsuoka |
Organization
M&I Science CORP.
Division name
Clinical Development Department
Zip code
531-0071
Address
NAKATSUGRAND Bld.10F, 1-17-26, Nakatsu, Kita-ku, Osaka-Shi, Osaka, Japan
TEL
06-7878-6780
Homepage URL
m.matsuoka@mis21.co.jp
Sponsor or person
Institute
M&I Science CORP.
Institute
Department
Personal name
Funding Source
Organization
Bourbon corporation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Commiittee, Faculty of Medicine, Juntendo University
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
hongo-rinri@juntendo.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 21 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 28 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
(Exclusion criteria continued)
11) Pregnant women.
12) Subjects who are deemed inappropriate by the examining physician and principal investigator or researcher in charge of the study.
13) Subjects who plan to participate in other clinical trials (research) during the study period.
14) Subjects who have difficulty in complying with the recording of various questionnaires."
Management information
Registered date
| 2024 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060838
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| Registered date | File name |
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