UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042814 |
|---|---|
| Receipt number | R000048857 |
| Scientific Title | INVERSEASSOCIATION BETWEEN GLUTAMATE AND SODIUM INTAKE IN VIETNAMESE |
| Date of disclosure of the study information | 2020/12/22 |
| Last modified on | 2020/12/22 16:15:55 |
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Basic information
Public title
INVERSE ASSOCIATION BETWEEN GLUTAMATE AND SODIUM INTAKE IN VIETNAMESE
Acronym
Dietary L-glutamate and sodium intake
Scientific Title
INVERSEASSOCIATION BETWEEN GLUTAMATE AND SODIUM INTAKE IN VIETNAMESE
Scientific Title:Acronym
Dietary L-glutamate and sodium intake
Region
| Asia(except Japan) |
Condition
Condition
Adults with pre-hypertension
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of free glutamate intake and sodium consumption in subjects with low free glutamate and normal free glutamate intake after receiving education to reduce sodium in Vietnamese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sodium intake is different after 6 weeks of a sodium restricted diet in those subjects with low L-glutamate and normal L-glutamate intake
Key secondary outcomes
Stress level is different after 6 weeks of a sodium restricted diet in those subjects with low L-glutamate and normal L-glutamate intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low L-glutamate intake in a 6 weeks sodium restricted diet.
Interventions/Control_2
Normal L-glutamate intake in a 6 weeks sodium restricted diet.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Systolic 120 - 139 mmHg or diastole blood pressure 80 - 90 mmHg, have a sodium intake more than >4000
2) Subjects who are able to participate in the study for 16 weeks
3) Subjects who give the written informed consent.
Key exclusion criteria
1) Those who are on a special diet
2) Pregnant and lactating women.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Hien |
| Middle name | Thi Thu |
| Last name | Vu |
Organization
National Institute of Nutrition, Vietnam
Division name
Biochemical and Nutrition Metabolism Department
Zip code
Not applicable
Address
48B Tang Bat Ho Street, Hanoi
TEL
84-24-3971-0576
hienvuthithu.nin@gmail.com
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Yamamoto |
Organization
Jumonji University
Division name
Department of Food and Nutritional Sciences
Zip code
352-8510
Address
2-1-28 Sugasawa, Niiza-City, Saitama, Japan
TEL
048-260-7613
Homepage URL
yamamotoshigeru426@gmail.com
Sponsor or person
Institute
Jumonji University
Institute
Department
Personal name
Funding Source
Organization
Jumonji University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Nutrition, Vietnam
Address
48B Tang Bat Ho Street, Hanoi
Tel
842439710576
hienvuthithu.nin@gmail.com
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 | 12 | Month | 22 | Day |
Related information
URL releasing protocol
not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not applicable
Number of participants that the trial has enrolled
42
Results
The sodium reduction in the normal L-glutamate group (at week 6, L-glutamate was 1,404+/-1677 mg/day and Na intake was 3,3 g/day with a sodium reduction rate of 46%) was higher than the low L-glutamate group (L-glutamate: 657+/-380 mg/day and Na intake of 4,6 g/day with a sodium reduction rate was 22%). There was no significant variation in stress indicators in both groups.
Results date posted
| 2020 | Year | 12 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Average age 61.8, BMI 23kg/m2, urine sodium excretion 7 g/d, systolic between 120 to 139 mmHg or diastole 80 - 89 mmHg.
Participant flow
After the implementation of the salt reduction education (target sodium intake 2 g / day), various indicators were measured over time (6 weeks) in the normal L-glutamate group or the low L-glutamate group. Chromogranin A (CgA) used as a stress index was measured using the ELISA method from saliva.
Adverse events
Not applicable
Outcome measures
Blood pressure, weight, height, urinary sodium and potassium excretion, chromogranin-A (CgA pmol/mg protein) from saliva and free L-glutamate from food.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2012 | 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 | 12 | Month | 22 | Day |
Last modified on
| 2020 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048857
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