UMIN-CTR Clinical Trial

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
Email	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
Email	yamamotoshigeru426@gmail.com

Sponsor
Institute	Jumonji University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048857