UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004436 |
|---|---|
| Receipt number | R000005180 |
| Scientific Title | Randomized-controlled trial for an effect of a long-term micronutrients supplement on endothelial function. |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2022/01/31 22:33:05 |
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Basic information
Public title
Randomized-controlled trial for an effect of a long-term micronutrients supplement on endothelial function.
Acronym
Randomized-controlled trial for micronutrient supplement on endothelial function.
Scientific Title
Randomized-controlled trial for an effect of a long-term micronutrients supplement on endothelial function.
Scientific Title:Acronym
Randomized-controlled trial for micronutrient supplement on endothelial function.
Region
| Japan |
Condition
Condition
Endothelial dysfunction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
itamin B6, B12, C and folic acids intakes were associated with reduced risks of cardiovascular disease probably through the improvement of endothelial function. However, few studies have examined whether these nutrient intakes improve endothelial function.
Then, the purpose of this trial is to examine whether consumption of micronutrient supplement rich in these nutrients improve endothelial function by a randomized-controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Endothelial function estimated by Flow Mediated Dilatation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
For the first 2 months, participants drink "V cresc berries" (Nutri CO., Ltd.: Vitamin B6 5mg, Vitamin B12 10micro-gram, vitamin C 500mg, folic acids 800 micro gram per 125ml per one pack) on every morning. After the 2 months, they keep their daily life for 2 months.
Interventions/Control_2
For the first 2 months, participants keep their daily life. After the 2 months, they drink "V cresc berries" (Nutri CO., Ltd.: Vitamin B6 5mg, Vitamin B12 10micro-gram, vitamin C 500mg, folic acids 800 micro gram per 125ml per one pack) on every morning for 2 months.
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
| 79 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy population who are body mass index >= 25 or waist circumference >= 85cm in men, 90 cm in women, or hypertension (systolic blood pressure >= 130mmHg or diastolic blood pressure >= 85mmHg) or glucose abnormality (fasting serum glucose >= 110mg/dL) or lipid abnormality (triglyceride >= 150mg/dL or HDL-cholesterol < 40mg/dL) in the last one year.
Key exclusion criteria
Medication for diabetes, hypertension or lipid abnormality.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyasu Iso |
Organization
Graduate school of Medicine, Osaka University
Division name
Public Health
Zip code
Address
2-2 Yamadaoka, Suita-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate school of Medicine, Osaka University
Division name
Public Health
Zip code
Address
TEL
Homepage URL
m_koutatsu_@hotmail.com
Sponsor or person
Institute
Public Health, Graduate school of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Nutri 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
Address
Tel
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
| 2010 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jcbn/64/3/64_17-56/_article/-char/en
Number of participants that the trial has enrolled
127
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 07 | Day |
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
| 2010 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005180
