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


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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005180


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name