UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045127 |
|---|---|
| Receipt number | R000051100 |
| Scientific Title | Double-blind RCT for the novel low-sodium processed foods. |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2021/08/10 12:09:29 |
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Basic information
Public title
The effect of the low-sodium and high-potassium processed foods for lower blood pressure in Japanese men: a randomized, double-blind controlled trial.
Acronym
Double-blind RCT for the novel low-sodium processed foods.
Scientific Title
Double-blind RCT for the novel low-sodium processed foods.
Scientific Title:Acronym
Novel low-sodium processed trial.
Region
| Japan |
Condition
Condition
Hypertensive or healthy subjects
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We developed a low-sodium, high potassium processed foods which could not be discriminated against the regular diet on neither appearance nor flavor so that we can make it a double-blind controlled trail. Using these low-sodium, high potassium processed foods, we estimate the effect on blood pressure decreasing between Japanese males older than 35 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in blood pressure.
Key secondary outcomes
Changes in urinary excretion of sodium and potassium
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intervention group: The menu for intervention group is designed as low-sodium and high-potassium diet for six weeks. The lunch-boxes are just the same with the ordinary diet for the control group not only in appearance and flavor but the contents of nutrition except for sodium and potassium.
Interventions/Control_2
Control group: The menu for control group is designed regular diet for six weeks. The lunch-boxes are just the same with the diet for the intervention group not only in appearance and flavor but the contents of nutrition except for sodium and potassium.
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
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Male, 35 years of age or older
Key exclusion criteria
(1) under antihypertensive medication
(2) have kidney disease
(3) taking new medicine which may have a strong influence on urine excretion of sodium during the intervention period
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Hayabuchi |
Organization
Nara Women's university, Japan
Division name
Faculty of Human Life and Environment
Zip code
630-8506
Address
Kitauoyahigashimachi, Nara, Japan
TEL
0742-20-3488
h.hayabuchi@cc.nara-wu.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Umeki |
Organization
Fukuoka Women's University
Division name
Graduate School
Zip code
813-8529
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka, 813-8529, Japan
TEL
092-661-2411
Homepage URL
umeki@fwu.ac.jp
Sponsor or person
Institute
Fukuoka Women's University
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Women's University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Fukuoka Women's University
Address
1-1-1 Kasumigaoka, Higashi-ku, Fukuoka
Tel
092-661-2411
soumu2@fwu.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
| 2021 | Year | 08 | Month | 20 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
187
Results
In a questionnaire after the intervention period, 52 of 93 in the intervention group and 56 of 94 participants in the control group reported that they consumed a regular diet throughout the intervention period (p= 0.61, compared by chi-square test).
Mean SBP did not change in the intervention group, but increased 1.7 (95% CI: 0.8, 2.6) mm Hg in the control group.
Results date posted
| 2021 | Year | 07 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
202 men
aged 35 to 67 years without current antihypertensive medication.
There was no difference in age, height, body weight, BMI, SBP and DPB between two groups.
Participant flow
194 of 202 provided written informed consent.
They were randomly assigned into two groups.
Finally, 93 in the intervention group and 94 in the control group were included in the analysis.
Adverse events
N/A
Outcome measures
Blood pressure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2021 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051100
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