Unique ID issued by UMIN | UMIN000041581 |
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Receipt number | 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 | 2021/10/18 17:33:01 |
Vegetable and Fruit Basket for Blood Pressure Lowering -Randomized controlled crossover trial pilot study
VEGA-FLOW trial
Vegetable and Fruit Basket for Blood Pressure Lowering -Randomized controlled crossover trial pilot study
VEGA-FLOW trial
Japan |
Adult
Cardiology | Adult |
Others
NO
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.
Efficacy
Change in urinary sodium potassium ratio among baseline, the end of intervention period and the and of non-intervention period.
Amount of vegetable and fruits ingested. Home blood pressure changes among baseline, the end of intervention period and the and of non-intervention period.
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
No treatment
2
Prevention
Food |
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.
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.
20 | years-old | <= |
60 | years-old | >= |
Male and Female
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.
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.
13
1st name | Atsushi |
Middle name | |
Last name | Satoh |
Fukuoka University
Department of preventive medicine and public health
8140180
7-45-1, Nanakuma, Jonan, Fukuoka, Fukuoka, JAPAN
0928011011
atsushis@fukuoka-u.ac.jp
1st name | Atsushi |
Middle name | |
Last name | Satoh |
Fukuoka University
Department of preventive medicine and public health
8140180
7-45-1, Nanakuma, Jonan, Fukuoka, Fukuoka, JAPAN
0928011011
atsushis@fukuoka-u.ac.jp
Fukuoka University, Department of preventive medicine and public health
Ministry of Education
Japanese Governmental office
Fukuoka University Clinical Research and Ethics Centre
7-45-1, Nanakuma, Jonan, Fukuoka, Fukuoka, JAPAN
0928011011
fumed-ethics@fukuoka-u.ac.jp
NO
2020 | Year | 10 | Month | 01 | Day |
Partially published
Main results already published
2020 | Year | 07 | Month | 20 | Day |
2020 | Year | 11 | Month | 04 | Day |
2020 | Year | 11 | Month | 05 | Day |
2021 | Year | 03 | Month | 31 | Day |
2020 | Year | 08 | Month | 27 | Day |
2021 | Year | 10 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046460
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