- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07397754
Sodium-rich COndiments Unifying Health and Taste (Scout)
Study Overview
Status
Detailed Description
Hypertension is the leading risk factor for cardiovascular diseases (CVDs) in older adults. While absolute dietary sodium reductions remain vital for prevention, effective long-term management must take stock of sensorial efficacy and acceptance, alongside the corresponding impacts on health. In Asia, this phenomenon is distinct due to a genetic predisposition of the population to salt sensitivity (increased risk), and a distinct food culture characterised by regional condiments (e.g. soy sauce, fermented bean paste).
The aim of this research is to develop an evidence-based classification for sodium-rich condiments (natremic index) based on their CVD-related risks. Perceived saltiness intensity is influenced by factors beyond the total amount of sodium consumed (e.g. flavour enhancers like MSG, tastes synergism etc.).
Similarly, while hypertension is predisposed by excessive sodium intake, growing evidence also suggests the potential role of bioactive compounds and ingredients (including some identified from Asian-style condiments e.g. spices, soya-derived flavonoids) that may elicit cardiovascular protective properties.
Contrary to generic recommendations that focused solely on absolute sodium reduction, sustainable solutions must simultaneously address concerns surrounding long-term health and consumer acceptance.
Much like the well-established glycemic index, it is hypothesised that the development of a natremic index, designed to evaluate and classify sodium-rich condiments according to their risks to cardiovascular health will serve as a vital, first of its kind strategy that can reliably guide public health recommendations, and spearhead next-generation innovations in the food and nutrition industry. The proposed research is split into two main parts that will investigate in detail three sodium-rich condiments commonly used in Asia cuisines: light soy sauce (condiment 1), fermented bean paste (condiment 2), and table salt (control), from sensory and health perspectives
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Darel Toh, PhD
- Phone Number: 64074149
- Email: darel_toh@a-star.edu.sg
Study Contact Backup
- Name: Bhupinder Kaur, MSc
- Phone Number: 64074355
- Email: bhupinder_kaur@a-star.edu.sg
Study Locations
-
-
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Singapore, Singapore, 117599
- Recruiting
- Clinical Nutrition Research Centre
-
Contact:
- Darel Toh Wee Kiat, PhD
- Email: darel_toh@a-star.edu.sg
-
Contact:
- Bhupinder Kaur, MSc
- Email: bhupinder_kaur@a-star.edu.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥ 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
Exclusion Criteria:
- 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
- Photophobic (sensitivity to intense lights and colours), particularly to intense red lights
- Has sinus problems problems that affect taste and smell
- Involvement in other clinical studies that may influence the outcome of the study
- An ASTAR Staff.
- A study team member or their immediate family member
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control porridge with no condiments
This arm will consist of plain porridge which participants will consume.
|
To examine acute cardiovascular health response to plain porridge.
|
|
Experimental: Porridge with light soya sauce
This arm will consist of plain porridge with light soya sauce which participants will consume.
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To examine acute cardiovascular health response to plain porridge with saltiness-matched light soya sauce
|
|
Experimental: Porridge with fermented bean paste
This arm will consist of plain porridge with fermented bean paste which participants will consume.
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To examine acute cardiovascular health response to plain porridge with saltiness-matched fermented bean paste
|
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Experimental: Porridge with table salt
This arm will consist of plain porridge with table salt which participants will consume.
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To examine acute cardiovascular health response to plain porridge with saltiness-matched table salt.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Endopat assessment
Time Frame: EndoPAT assessments which will serve as the primary outcome of interest will be measured at postprandial intervals (up to 3 measurements) over 4 hours.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ambulatory blood pressure
Time Frame: 24 hour period consisting of: Postprandially 15 minutes intervals (over 4 hours), 30 minutes interval (after 4 hours)
|
The ambulatory blood pressure monitor will be attached and programmed for blood pressure measurements at pre-determined intervals.
Blood pressure measurements will be taken at 15 minutes interval during the postprandial study duration (4 hours), 30 minutes interval (after the 4 hours) when participant is awake, and hourly when the participants are asleep.
During each measurement, participants must be standing, seated or lie still, stay relaxed and silent.
If seated they should keep their feet flat on the floor (not crossed).
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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"
Time Frame: Test meal is consumed for 15 minutes. At the end of 15 minutes, palatibility questionnaire is completed.
|
Palatability appetite questionnaire, rated on a visual analogue scale.
To place a vertical mark on the thick line to indicate how person feels at that moment in response to various questions.
At opposite ends of each line are descriptors which should be read carefully before placing the vertical line.
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Test meal is consumed for 15 minutes. At the end of 15 minutes, palatibility questionnaire is completed.
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Serum and Plasma sodium and potassium
Time Frame: Blood will be sampled at timepoints, t = 0 minute (Baseline) and at t = 30, 45, 60, 120, 180, 240 minute for each session
|
Serum and plasma collected are for sodium and potassium assessment
|
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
Time Frame: t=0 minute (Baseline), and t= 30, 45, 60, 120, 180, 240 minute for each session.
|
Subjective appetite questionnaire, rated on a 0-100 visual analogue scale.
0 corresponds to "not at all" and 100 corresponds to "extremely".Questions usually used are "How hungry are you?"
"How full are you?"
"How strong is your desire to eat?" "How much food do you think you could eat?"
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t=0 minute (Baseline), and t= 30, 45, 60, 120, 180, 240 minute for each session.
|
|
Taste acuity test
Time Frame: Test administered once at each session (5 sessions). Each test takes 20 minutes.
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Sensory method to assess participant's recognition, detection and aversion threshold for sweet, salty, umami, sour and bitter taste.
Up to 25 samples (approximately 10 milimetre each) will be evaluated per test session.
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Test administered once at each session (5 sessions). Each test takes 20 minutes.
|
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Ultrasound scan of carotid intima-media thickness
Time Frame: At baseline only
|
The ultrasound scan measures the thickness of the carotid intima-media layers on the side of the neck which is a marker for CVD risk
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At baseline only
|
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Evaluation
Time Frame: Administered during session4, 5 and 6. Each evaluation takes1 hour.There is a 1-minute inter-stimulus break between each sample for palate cleansing.
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Participants will taste up to 25 test samples (undosed or dosed with various condiments with varying concentrations).
A mandatory inter-stimulus break of one-minute is enforced between each sample to reduce possible fatigue and allow time for palate cleansing.
The QDA method features participants rating pre-defined sensory attributes (e.g.
salty taste intensity) on a 0-100 VAS scale.
During sample evaluation, participants will be instructed to place the entire sample in their mouth, hold it in, swirl for 5 seconds before swallowing, then rate the taste intensity of the sample marked from 'low' (0) to 'high' (100) on a scale in Compusense
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Administered during session4, 5 and 6. Each evaluation takes1 hour.There is a 1-minute inter-stimulus break between each sample for palate cleansing.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health and lifestyle relevant questionnaire to to assess eligibility for inclusion/exclusion criteria.
Time Frame: This is conducted at the Screening Visit, 1 time only. Takes 15 minutes to complete.
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This is to evaluate the participants eligibility for the study.
Section A: Participant information, Section B: Medical and Health History, Section C: Lifestyle and Diet.
Section A, B and C are questions with "Yes" or "No" to be answered.
Section D: Physical Acitvity where participants select only one description that best represents their usual physical activity for leisure over the past 3 months.
|
This is conducted at the Screening Visit, 1 time only. Takes 15 minutes to complete.
|
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3 day food records
Time Frame: 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)
|
Dietary intake will be assessed by documenting all foods and beverages consumed over 3 consecutive days, typically including 2 weekdays and 1 weekend day.
Participants will record all foods and beverages consumed using household measures.
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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)
Time Frame: Administered once over the course of the study. Takes about 1-2 minutes to complete each item.
|
The Gastrointestinal Symptom Rating Scale (GSRS) is a validated, self-administered questionnaire used to assess the severity of gastrointestinal symptoms.
It consists of 15 items grouped into five symptom domains: reflux, abdominal pain, indigestion, diarrhoea, and constipation.
Each item is rated on a 7-point Likert scale ranging from 1 (no discomfort) to 7 (very severe discomfort).
Higher scores indicate greater gastrointestinal symptom severity.
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Administered once over the course of the study. Takes about 1-2 minutes to complete each item.
|
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Council on Nutrition Appetite Questionnaire (CNAQ)- Rate items like appetite quality, fullness, hunger, taste of food, and eating frequency on a 5-point Likert scale (e.g., from "very poor" to "very good"). A total score is often used.
Time Frame: Administered only once over the course of the study. Takes about 1-2 minutes to complete each item.
|
An 8-item self-reported appetite assessment tool used in clinical research to evaluate appetite status.
|
Administered only once over the course of the study. Takes about 1-2 minutes to complete each item.
|
|
Pittsburgh Sleep Quality Index (PSQI)- Self-rated items,combined to generate 7 component scores to obtain a global PSQI score ranging from 0 to 21, with higher scores indicating poorer sleep quality
Time Frame: Administered only once over the course of the study. Takes about 1-2 minutes to complete each item
|
Validated, self-administered questionnaire used to assess subjective sleep quality and sleep disturbances over the previous 1 month.
|
Administered only once over the course of the study. Takes about 1-2 minutes to complete each item
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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