An interventional study of Reduction in Salt and Sugar and The potentiometer in Cardiovascular Diseases, sponsored by Sunway University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Sunway University · Not applicable, Interventional, and Health services research
This project aims to address the significant burden of cardiovascular disease in Malaysia, especially the high prevalence of hypertension with excessive salt and sugar intake. The study targets the university campus community, recognizing reliance on out-of-home food options and the potential impact of reducing salt and sugar in campus foods on overall health. The project aims to assess the knowledge, attitudes, and practices related to salt and sugar intake among students, staff, and campus canteen staff. Through a combination of surveys, dietary assessments, urine analysis, and body composition measurements, the study aims to generate valuable insights into effective strategies for reducing salt and sugar intake and improving cardiovascular health among the campus population.
Research Background:
Cardiovascular disease (CVD) represents a significant global health challenge, particularly in developing countries, where it stands among the primary causes of premature death and disability. In Malaysia, CVD remains the leading cause of premature mortality, with high blood pressure (BP) consistently identified as a major contributor. Despite efforts to address hypertension, the 2019 National Health and Morbidity Survey (NHMS) revealed a concerning 30% prevalence of hypertension among Malaysian adults aged 18 and above, with nearly two-thirds of hypertensive individuals remaining undiagnosed. Research has established that even a slight increase of 2mmHg in systolic blood pressure significantly elevates mortality rates from stroke and ischemic heart disease in adults.
The association between salt/sodium intake and BP has been well-documented, with reductions in salt/sodium intake shown to correlate with lower BP levels and decreased cardiovascular (CV) mortality. However, the mean salt intake in Malaysia significantly exceeds the WHO-recommended limit of \<5 gm/day, with the WHO setting a target to reduce population salt intake by 30% by 2025.
A notable trend in Malaysia is the increasing prevalence of dining out, particularly in urban areas and among young adults. This shift towards consuming meals away from home, including breakfast, underscores the importance of addressing salt and sugar intake in out-of-home foods. Studies conducted among Malaysians have highlighted a perception of high salt intake in the out-of-home food sector, with both consumers and food operators advocating for comprehensive salt reduction policies and improved awareness among stakeholders.
University campuses, including Sunway University and Sunway College, serve as critical environments where students and staff frequently rely on campus vendors for meals. Recognizing the impact of campus food environments on dietary habits, this study aims to assess the effects of salt and sugar reduction in foods sold on campus, targeting both the campus community and canteen staff. By investigating knowledge, attitudes, and practices (KAP) related to salt and sugar intake among students, staff, and canteen personnel, the study seeks to identify barriers and enablers to salt and sugar reduction and propose strategies for promoting healthier dietary habits.
Aims and Objectives:
The overarching goal of the study is to evaluate the effects of salt and sugar reduction in campus foods and address consumption patterns among Sunway University and Sunway College students and staff. The study comprises three main parts:
Part 1 involves assessing KAP on dietary salt and sugar intake among the campus community. Part 2 investigates KAP, perceptions, barriers, and enablers of salt and sugar reduction among campus canteen staff. Part 3 conducts a 6-month interventional study on salt and sugar reduction in foods sold on campus. Separated into Study A and Study B, where Study A mainly focuses on surveys and coming up with further recommendations. Study B is composed of utilizing urine samples and body composition measurements to assess the outcome of lowering sodium intake.
Study Methodology:
The study will involve surveying participants from the Sunway University and Sunway College community, including students, staff, and canteen personnel. Various instruments, including online questionnaires, urine analysis, anthropometric measurements, and dietary records, will be utilized to assess KAP, perceptions, and dietary habits related to salt and sugar intake.
Statistical analyses will be conducted using SPSS version 27, with comparisons of means and logistic regression analysis employed to determine factors associated with intention to reduce salt and sugar intake. The study aims to provide insights into the effectiveness of salt and sugar reduction interventions in campus food environments and their impact on cardiovascular health outcomes.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
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Part 1: KAP on dietary salt and sugar intake
Part 2: KAP, Perception, Barriers and Enablers of Salt and Sugar Reduction among Campus Canteen Staff
Part 3: An interventional study for 6 months will expose them to foods sold on campus that have reduced salt and sugar.
For intervention group
For control group
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lowering the salt and sugar in selected samples of foods this will be performed using dry ashing method, followed by flame atomic absorption spectrometry (FAAS) at the Department of Nutrition, Universiti Putra Malaysia.
Other: Reduction in Salt and Sugar · Device: Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)
Participants have to provide urine samples for the measurement of urinary sodium, potassium, chloride, and creatinine, have body composition and anthropometric measurements taken, perform 24-hour dietary records, perform saltiness intensity perception and pleasantness ratings of the foods on campus, at three timepoints - at the start of the study, after 3 months and after 6 months.
Device: The potentiometer
150 participants who are grouped under interventions, their data will be collected according to the alterations of sodium and sugar intake and then compared with the control group. Instruments include urine analysis, providing two spot urine samples - first-morning void and last void in the evening before leaving campus, at three-time points - at the start of the study, after 3 months, and after 6 months. This will yield a total of 300 × 2 × 3 = 1800 samples. Urine electrolytes (sodium, potassium, chloride) and creatinine will be measured using the potentiometry method (Alinity Abbott) at the laboratory department of Sunway Medical Centre, Bandar Sunway.
The potentiometer is utilized for the quantitative analysis of electrolytes present in urine samples. The potentiometer used for urine electrolytes analysis is a specialized device equipped with electrodes and sensors designed to detect and measure the concentration of specific electrolytes in urine samples. It employs potentiometric principles to generate electrical signals proportional to the concentration of ions present in the sample.
Also known as: Urinal measurement device
Dry ashing method involves heating the food samples in a controlled environment to remove organic matter and moisture, leaving behind inorganic residues (ashes) containing the salts and minerals present in the food. Flame Atomic Absorption Spectrometryis utilized to measure the levels of sodium and potassium (components of salt) as well as carbon and hydrogen (components of sugar) in the ashed food samples. By determining the concentrations of these elements, the salt and sugar content of the food samples can be quantified accurately.
Part 1:Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community
Firstly, understanding the community's Knowledge, Attitude, and Practice can provide baseline data on the level of awareness regarding the health implications. Addressing misconceptions and promoting healthier dietary choices. Also assessing attitudes towards reduction provides insight into the community's readiness to embrace dietary changes. The online validated questionnaire will assess: 1. Socio-demographic and lifestyle factors - questions such as age, gender, ethnicity, medical history, smoking and alcohol-drinking practices 2. Knowledge, Attitude, and Practice towards dietary salt and sugar intakes, and diabetes 3. Barriers and enablers for salt reduction Target sample size of 1000 participants is set to consider mid-study drop-outs.
Time frame: Baseline
Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community (canteen staff)
Food providers' understanding of the importance of salt and sugar reduction directly influences the choices they make in the kitchen. The online validated questionnaire will assess: 1. Knowledge, Attitude, and Practice towards salt and sugar usage in food preparation (including on campus) and in dietary intake 2. Perception, barriers and enablers for salt reduction during food preparation on campus The targeted number of participants is around 50 people.
Time frame: baseline
Part 3 Study A: Interventional study on salt and sugar reduction of selected foods sold on campus (students and staff )
Selected samples of food sold on campus will be analysed for their sodium and sugar contents at baseline and also 3 months after the intervention of salt and sugar reduction. This will be performed using dry ashing method, followed by flame atomic absorption spectrometry (FAAS) at the Department of Nutrition, Universiti Putra Malaysia. Scale Title: Sodium Content Determination Scale Range: 0 to 100 milligrams per kilogram (mg/kg) Interpretation: Higher scores indicate higher levels of sodium content, which may be considered a worse outcome in the context of reducing sodium intake. targeted 5 food samples per vendor for 17 vendors - will yield a total number of 170 samples.
Time frame: baseline and 3 months after invention
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Blood Pressure)
Clinical measurements indicative of vascular health namely systolic blood pressure (SBP), diastolic blood pressure (DBP) and pulse rate will be taken using an automated blood pressure monitor (HEM- 7121, Omron, Japan) after the subjects have rested for 5 min. Measurement units: millimeters of mercury (mmHg)
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Wasit to Hip ratio)
The height, waist and hip circumferences will be measured using a measuring tape and waist-hip ratio (WHR) will be calculated by dividing waist circumference by hip circumference. Measurement units: cm/inches
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Body Mass Index and Total body fat)
A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will be used to determine body mass index (BMI) Measurement units = kg/m2 , total body fat (TBF) = kg/m 2. The cut-off points for overweight, obesity, overall adiposity (TBF) and central adiposity (WHR) are ≥23 kg/m 2 , ≥25 kg/m 2
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Fats)
A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will be used to measure visceral fat (VF) measurement unit = %, subcutaneous fat (SF) measurement unit = %, skeletal muscle percentage (SM) measurement unit = % The cut-off points for overweight, obesity, overall adiposity (TBF) and central adiposity (WHR) 20% (males) or 30%
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Resting Metabolic Rate)
A bio-impedance body composition scale (Omron HBF-375 Karada Scan) will measure resting metabolic rate, measurement unit = kcal/day. The cut-off points for overweight, obesity, overall adiposity (TBF), and central adiposity (WHR) 0.90 (males) or 0.85 (females)
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
Part 3 Study B: Assessment of saltiness intensity perception
Completed two rating scales assessing the intensity of saltiness of the selected foods sold on campus they perceived (hereafter referred to as 'intensity perception'), and the extent to which they liked or disliked this level of saltiness of the selected foods sold on campus (hereafter referred to as 'pleasantness rating'). The perceived saltiness intensity will be measured by using the generalised Labelled Magnitude Scale (gLMS) (8) where the participants will be asked to make a horizontal marking on the paper versions of it. A 100 mm scale was constructed with six different descriptors which were ''barely detectable'',''weak'', ''moderate'', ''strong'', ''very strong'' and ''strongest imaginable sensation of any kind'' were spaced at 1.4 mm, 6 mm, 17 mm, 35 mm, 53 mm, and 100 mm, respectively.
Time frame: baseline and 3 months after invention
Part 3 Study B: Assessment of pleasantness
For pleasantness, the Labelled Affective Magnitude (LAM) scale (9) will be used. It is a 100 mm scale that is constructed with 11 different levels - ''greatest imaginable disliking'' (0 mm), ''dislike extremely''(12 mm), ''dislike very much'' (22 mm), ''dislike moderately''(34 mm), ''dislike slightly'' (45 mm), ''neither like or dislike''(50 mm), ''like slightly'' (56 mm), ''like moderately'' (68 mm), ''like very much'' (78 mm), ''like extremely'' (87 mm), ''greatest imaginable liking'' (100 mm).
Time frame: baseline and 3 months after invention
Part 3 Study B: Urine analysis of salt and sugar reduction of selected foods sold on campus
Accessing the urine electrolytes (sodium, potassium, chloride) and creatinine will be measured using the potentiometry method (Alinity Abbott). Intervention and control participants will provide two spot urine samples - first morning void and last void in the evening before leaving campus. This will yield a total of 300 × 2 × 3 = 1800 samples. Sodium: Minimum value: 0 millimoles per liter (mmol/L), Maximum value: 200 mmol/L Potassium: Minimum value: 0 mmol/L, Maximum value: 20 mmol/L Chloride: Minimum value: 0 mmol/L, Maximum value: 200 mmol/L Creatinine: Minimum value: 0 milligrams per deciliter (mg/dL), Maximum value: 500 mg/dL Interpretation: Higher scores for urine electrolytes could be associated with different health conditions or dietary factors. Higher levels may imply a worse outcome.
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community
For pleasantness, the Labelled Affective Magnitude (LAM) scale (9) will be used. It is a 100 mm scale that is constructed with 11 different levels - ''greatest imaginable disliking'' (0 mm), ''dislike extremely''(12 mm), ''dislike very much'' (22 mm), ''dislike moderately''(34 mm), ''dislike slightly'' (45 mm), ''neither like or dislike''(50 mm), ''like slightly'' (56 mm), ''like moderately'' (68 mm), ''like very much'' (78 mm), ''like extremely'' (87 mm), ''greatest imaginable liking'' (100 mm).
Time frame: baseline
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — The data collected from the study will be encrypted via a password-protected file and can only be accessed by the researchers of this study. The password-protected file will be kept at Sunway University for up to five years (only if this research is successfully published in a scientific journal, presented at a conference, or published through other media).
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