UMIN-CTR Clinical Trial

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
Email

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
Email	m_koutatsu_@hotmail.com

Sponsor
Institute	Public Health, Graduate school of Medicine, Osaka University
Institute
Department

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
Email

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005180