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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041581
Receipt No. R000046460
Scientific Title Vegetable and Fruit Basket for Blood Pressure Lowering -Randomized controlled crossover trial pilot study
Date of disclosure of the study information 2020/10/01
Last modified on 2020/08/26

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Basic information
Public title Vegetable and Fruit Basket for Blood Pressure Lowering -Randomized controlled crossover trial pilot study
Acronym VEGA-FLOW trial
Scientific Title Vegetable and Fruit Basket for Blood Pressure Lowering -Randomized controlled crossover trial pilot study
Scientific Title:Acronym VEGA-FLOW trial
Region
Japan

Condition
Condition Adult
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a cross-over pilot study to determine feasibility of a randomized controlled trial of an intervention in which vegetable and fruits full of potassium are provided to the participants for three weeks to lower their blood pressure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in urinary sodium potassium ratio among baseline, the end of intervention period and the and of non-intervention period.
Key secondary outcomes Amount of vegetable and fruits ingested. Home blood pressure changes among baseline, the end of intervention period and the and of non-intervention period.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The duration of the intervention and non-intervention are both three weeks. One week of wash-out is taken between two periods.
The intervention is started with nutritional education for the participants. Packages of vegetable and fruits equivalent 600 mg of potassium per day are provided to the participants for three weeks. Data on the amount of food intake and a urinary sample is taken at the end of intervention period.
Interventions/Control_2 The non-intervention is started with nutritional education for the participants (same as intervention). No vegetable or fruits are provided to the participants during the period. A urinary sample is taken at the end of non-intervention period.
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
20 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Men and women aged 20 to 60 years.
People who are able to walk by themselves.
People who agreed to the participation of this study and provided written informed consent.
Key exclusion criteria People who are taking anti-hypertensive drugs, diuretic drugs, or potassium drugs.
People whose eGFR are over 45 or taking dialysis treatment.
Hyperpotassemia.
People whose body mass index are over 30 kg/m2.
Diabetes mellitus.
Pregnant women.
People who are joining other trials.
People who are judged inappropriate to participate by medical doctors.

Target sample size 13

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Satoh
Organization Fukuoka University
Division name Department of preventive medicine and public health
Zip code 8140180
Address 7-45-1, Nanakuma, Jonan, Fukuoka, Fukuoka, JAPAN
TEL 0928011011
Email atsushis@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Satoh
Organization Fukuoka University
Division name Department of preventive medicine and public health
Zip code 8140180
Address 7-45-1, Nanakuma, Jonan, Fukuoka, Fukuoka, JAPAN
TEL 0928011011
Homepage URL
Email atsushis@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University, Department of preventive medicine and public health
Institute
Department

Funding Source
Organization Ministry of Education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka University Clinical Research and Ethics Centre
Address 7-45-1, Nanakuma, Jonan, Fukuoka, Fukuoka, JAPAN
Tel 0928011011
Email fumed-ethics@fukuoka-u.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
2020 Year 10 Month 01 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
2020 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 03 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
2020 Year 08 Month 27 Day
Last modified on
2020 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046460

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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