NCT07397754

Brief Summary

This research aims to develop an evidence-based classification for sodium-rich condiments (natremic index) based on their CVD-related risks. It is hypothesised that the acute cardiovascular and physiological response (effectively extrapolated to long-term CVD risks) to meals prepared with various sodium-rich condiments can be leveraged upon for the development of such an index that will systematically classify sodium-rich condiments based on the risk they present to cardiovascular health.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Sep 2025Sep 2026

Study Start

First participant enrolled

September 22, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2026

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

November 18, 2025

Last Update Submit

February 5, 2026

Conditions

Keywords

sodium intakenatremic indexelevated blood pressurecardiometabolic outcomescondimentsAsianvascular healthsensory evaluation

Outcome Measures

Primary Outcomes (1)

  • Endopat assessment

    EndoPAT test which will measure endothelial health and function at baseline. The EndoPAT test is a non-invasive procedure that involves the placement of probes on each index finger, followed by blood pressure cuff inflation for measurements of the arterial tone and blood flow responses (e.g. EndoPAT index).

    EndoPAT assessments which will serve as the primary outcome of interest will be measured at postprandial intervals (up to 3 measurements) over 4 hours.

Secondary Outcomes (7)

  • Ambulatory blood pressure

    24 hour period consisting of: Postprandially 15 minutes intervals (over 4 hours), 30 minutes interval (after 4 hours)

  • Palatability questionnaire rated on a visual analogue scale "Good" to "Bad"

    Test meal is consumed for 15 minutes. At the end of 15 minutes, palatibility questionnaire is completed.

  • Serum and Plasma sodium and potassium

    Blood will be sampled at timepoints, t = 0 minute (Baseline) and at t = 30, 45, 60, 120, 180, 240 minute for each session

  • Subjective appetite questionnaire

    t=0 minute (Baseline), and t= 30, 45, 60, 120, 180, 240 minute for each session.

  • Taste acuity test

    Test administered once at each session (5 sessions). Each test takes 20 minutes.

  • +2 more secondary outcomes

Other Outcomes (5)

  • Health and lifestyle relevant questionnaire to to assess eligibility for inclusion/exclusion criteria.

    This is conducted at the Screening Visit, 1 time only. Takes 15 minutes to complete.

  • 3 day food records

    Administered once during whole study. Record 3 days of food intake (over 72 hours). Recording can range from 5-15 minutes for every meal recorded (recording duration depends on how many meals to be recorded for the day)

  • Gastrointestinal Symptom Rating Scale (GSRS)

    Administered once over the course of the study. Takes about 1-2 minutes to complete each item.

  • +2 more other outcomes

Study Arms (4)

Control porridge with no condiments

EXPERIMENTAL

This arm will consist of plain porridge which participants will consume.

Other: Control porridge with no condiments

Porridge with light soya sauce

EXPERIMENTAL

This arm will consist of plain porridge with light soya sauce which participants will consume.

Other: Porridge with light soya sauce

Porridge with fermented bean paste

EXPERIMENTAL

This arm will consist of plain porridge with fermented bean paste which participants will consume.

Other: Porridge with fermented bean paste

Porridge with table salt

EXPERIMENTAL

This arm will consist of plain porridge with table salt which participants will consume.

Other: Porridge with table salt

Interventions

To examine acute cardiovascular health response to plain porridge.

Control porridge with no condiments

To examine acute cardiovascular health response to plain porridge with saltiness-matched light soya sauce

Porridge with light soya sauce

To examine acute cardiovascular health response to plain porridge with saltiness-matched fermented bean paste

Porridge with fermented bean paste

To examine acute cardiovascular health response to plain porridge with saltiness-matched table salt.

Porridge with table salt

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 50, \< 75 years old
  • Male or postmenopausal female (self-reported)
  • ≥ 50 kg body weight
  • Systolic blood pressure (≥ 130, \< 160 mmHg) or diastolic blood pressure (≥ 85, \< 100 mmHg)
  • Willing and able to follow intervention protocol
  • Ability to identify basic tastes (determined by taste discrimination test)
  • English speaking

You may not qualify if:

  • Prescribed and taking medication which may affect study outcomes (i.e. for blood pressure management, blood thinning etc.) in consultation with study physician (Prof Melvin Leow) and PI(Dr Darel Toh)
  • Type 1 or type 2 diabetes mellitus (i.e. fasting blood glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5 %)
  • Taking dietary supplements which may affect study outcomes one month prior to their first visit in consultation with study physician, PI and study team
  • Obesity (BMI ≥ 27.5 kg/m2)
  • History or known present diagnosis of hematological (G6PD and coagulation disorders), hepatic (hepatitis B and C), renal, gastrointestional or other relevant disease / disorders which may affect the outcomes of interest in consultation with study physician, PI and study team
  • History of arteriovenous shunt or mastectomy
  • Women who are pregnant, lactating or planning pregnancy
  • History or present diagnosis of HIV and/or tuberculosis
  • History of severe vasovagal syncope (blackouts or near faints) following blood draw
  • Drug abuse within last 5 years
  • Excessive alcoholic beverage consumption \> 2 servings per day (1 serving defined as 360 mL beer, 150 mL wine or 45 mL distilled spirits)
  • Smoking (cigarette, e-cigarette, cigar, pipe, vape)
  • Engaging in habitual vigorous physical activity (as defined by physical activity questionnaire-PAR)
  • Allergic or intolerance to intervention foods.
  • Dislike or unwilling to consume intervention foods
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Nutrition Research Centre

Singapore, 117599, Singapore

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Sodium Chloride, Dietary

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sodium ChlorideSodium CompoundsInorganic ChemicalsSodium, Dietary

Central Study Contacts

Darel Toh, PhD

CONTACT

Bhupinder Kaur, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 18, 2025

First Posted

February 9, 2026

Study Start

September 22, 2025

Primary Completion (Estimated)

September 22, 2026

Study Completion (Estimated)

September 22, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations