Sodium-rich COndiments Unifying Health and Taste
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Endopat assessment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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
排除标准
- •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
研究组 & 干预措施
Control porridge with no condiments
This arm will consist of plain porridge which participants will consume.
干预措施: Control porridge with no condiments (Other)
Porridge with light soya sauce
This arm will consist of plain porridge with light soya sauce which participants will consume.
干预措施: Porridge with light soya sauce (Other)
Porridge with fermented bean paste
This arm will consist of plain porridge with fermented bean paste which participants will consume.
干预措施: Porridge with fermented bean paste (Other)
Porridge with table salt
This arm will consist of plain porridge with table salt which participants will consume.
干预措施: Porridge with table salt (Other)
结局指标
主要结局
Endopat assessment
时间窗: 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).
次要结局
- 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.)
- Ultrasound scan of carotid intima-media thickness(At baseline only)
- Evaluation(Administered during session4, 5 and 6. Each evaluation takes1 hour.There is a 1-minute inter-stimulus break between each sample for palate cleansing.)
研究者
Darel Toh
Principal Investigator
Singapore Institute of Food and Biotechnology Innovation