Clinical Nutrition Research Centre
Singapore, 117599
Location status: Recruiting
NCT Number: NCT07397754
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.
Interested in participating?
Request Info50 year–75 year
All sexes
Interventional
Not applicable
Singapore, 117599
Location status: Recruiting
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To examine acute cardiovascular health response to plain porridge.
To examine acute cardiovascular health response to plain porridge with saltiness-matched light soya sauce
To examine acute cardiovascular health response to plain porridge with saltiness-matched fermented bean paste
To examine acute cardiovascular health response to plain porridge with saltiness-matched table salt.
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).
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).
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.
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
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?"
Time frame: Test administered once at each session (5 sessions). Each test takes 20 minutes.
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.
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
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.
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
Time frame: This is conducted at the Screening Visit, 1 time only. Takes 15 minutes to complete.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Bhupinder Kaur, MSc
CONTACT
Darel Toh, PhD
CONTACT
Singapore Institute of Food and Biotechnology Innovation
Other Gov
Acronym: Scout
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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