Sodium-rich COndiments Unifying Health and Taste
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorSingapore Institute of Food and Biotechnology Innovation
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥ 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)
Disqualifiers
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)
Trial design
Design model
Crossover
Treatments tested in this trial
Control porridge with no condiments
Other interventionTo examine acute cardiovascular health response to plain porridge.
Porridge with light soya sauce
Other interventionTo examine acute cardiovascular health response to plain porridge with saltiness-matched light soya sauce
Porridge with fermented bean paste
Other interventionTo examine acute cardiovascular health response to plain porridge with saltiness-matched fermented bean paste
Porridge with table salt
Other interventionTo examine acute cardiovascular health response to plain porridge with saltiness-matched table salt.
Treatment groups
32 Participants
are divided into 4 treatment groupsGroup A: Control porridge with no condimentsExperimental treatment 1 intervention
Group B: Porridge with light soya sauceExperimental treatment 1 intervention
Group C: Porridge with fermented bean pasteExperimental treatment 1 intervention
Group D: Porridge with table saltExperimental treatment 1 intervention
Trial outcomes
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).
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.Secondary outcomes
1
Ambulatory blood pressure
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
24 hour period consisting of: Postprandially 15 minutes intervals (over 4 hours), 30 minutes interval (after 4 hours)2
Palatability questionnaire rated on a visual analogue scale "Good" to "Bad"
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
Test meal is consumed for 15 minutes. At the end of 15 minutes, palatibility questionnaire is completed.3
Serum and Plasma sodium and potassium
Serum and plasma collected are for sodium and potassium assessment
Time frame
Blood will be sampled at timepoints, t = 0 minute (Baseline) and at t = 30, 45, 60, 120, 180, 240 minute for each session4
Subjective appetite questionnaire
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
t=0 minute (Baseline), and t= 30, 45, 60, 120, 180, 240 minute for each session.Other outcomes
1
Health and lifestyle relevant questionnaire to to assess eligibility for inclusion/exclusion criteria.
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
This is conducted at the Screening Visit, 1 time only. Takes 15 minutes to complete.2
3 day food records
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 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)3
Gastrointestinal Symptom Rating Scale (GSRS)
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 once over the course of the study. Takes about 1-2 minutes to complete each item.4
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.
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.Sponsors and contacts
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Source ClinicalTrials.gov