Cardiovascular DiseasesNCT06473038
Reducing Salt and Sugar in Campus Foods: A Malaysian Study
A study testing Reduction in Salt and Sugar, The potentiometer and Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS) in people with Cardiovascular Diseases, run by Sunway University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Reduction in Salt and Sugar, The potentiometer and Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1: KAP on dietary salt and sugar intake
- Students and staff of Sunway University and Sunway College aged 18 years and above
- Able to provide informed consent (verbal/written) to participate
- Understands English
- Part 2: KAP, Perception, Barriers and Enablers of Salt and Sugar Reduction among Campus Canteen Staff
- Canteen staff that are involved in food preparation aged 18 years and above
Show all 15Show fewer
- Able to provide informed consent (verbal/written) to participate
- Understands English
- 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
- Individuals who eat on campus food for at least 3 meals per week
- Consent to participate
- For control group
- Individuals who do not eat on campus food or for less than 3 meals per week
- Consent to participate
Who cannot join
- 1. Individuals with acute illness, psychological or psychiatric conditions
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Interventional Study of Salt and Sugar Reduction in Foods Sold On a University/College Campus in Malaysia
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Reduction in Salt and Sugar, The potentiometer, Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)
- Keywords
- Salt and Sugar Reduction, Knowledge, Attitude, and Practice (KAP), Hypertension
- Medical subject headings
- Cardiovascular Diseases, Behavior, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction in Salt and SugarOther
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 potentiometerDevice
Also called Urinal measurement device
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.
Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)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.
| Study group | Role | What they receive |
|---|---|---|
| Group that experience lower sodium intake | Active comparator | 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. Receives: Other: Reduction in Salt and Sugar; Device: Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS) |
| Control group | Other | 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. Receives: Device: The potentiometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- Socio-demographic and lifestyle factors - questions such as age, gender, ethnicity, medical history, smoking and alcohol-drinking practices
- Knowledge, Attitude, and Practice towards dietary salt and sugar intakes, and diabetes
- Barriers and enablers for salt reduction
Target sample size of 1000 participants is set to consider mid-study drop-outs.
Measured: 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:
- Knowledge, Attitude, and Practice towards salt and sugar usage in food preparation (including on campus) and in dietary intake
- Perception, barriers and enablers for salt reduction during food preparation on campus
The targeted number of participants is around 50 people.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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%
Measured: 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)
Measured: at three timepoints - at the start of the study, after 3 months and after 6 months
Secondary outcomes (4)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants who eat often foods sold on campus will be selected from the online validated questionnaire (part 1) in a randomized manner and they form the intervention group who will be eating the foods sold on campus that have reduced salt and sugar. Participants who do not eat often the food sold on campus will be the control group.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunway University
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Putra Malaysia
- Responsible party
- Principal investigator, YookChin Chia, Sunway University
- Investigators
- Yook Chia Chin, MD, Principal investigator, Sunway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473038
- Sponsor's protocol ID
- 20241904
- Status last verified
- Jun 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
Chia YC, Say YH, Cheng MH, Chung FFL, Lau TP, Ooi PB. Reduction of Salt and Sugar Contents in Canteen Foods and Intakes By Students and Staff at a Malaysian Higher Education Institution: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2025 Jul 21;14:e69610. doi: 10.2196/69610.
PubMed 40690753
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study of Salt and Sugar Reduction in Foods Sold On a University/College Campus in Malaysia
- ClinicalTrials.gov ID
- NCT06473038
- Acronym / sponsor ID
- 20241904
- Conditions
- Cardiovascular Diseases
- Keywords
- Salt and Sugar Reduction, Knowledge, Attitude, and Practice (KAP), Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sunway UniversityUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants who eat often foods sold on campus will be selected from the online validated questionnaire (part 1) in a randomized manner and they form the intervention group who will be eating the foods sold on campus that have reduced salt and sugar. Participants who do not eat often the food sold on campus will be the control group.
| Arm | Type | Receives |
|---|---|---|
| Group that experience lower sodium intake | Active comparator | Other: Reduction in Salt and Sugar, Device: Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)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. |
| Control group | Other | Device: The potentiometerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Part 1: KAP on dietary salt and sugar intake
- Students and staff of Sunway University and Sunway College aged 18 years and above
- Able to provide informed consent (verbal/written) to participate
- Understands English
- Part 2: KAP, Perception, Barriers and Enablers of Salt and Sugar Reduction among Campus Canteen Staff
Key exclusion criteria (1 listed)
- 1. Individuals with acute illness, psychological or psychiatric conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduction in Salt and Sugar150 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. | Other | Group that experience lower sodium intake |
| The potentiometerAlso: Urinal measurement deviceThe 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. | Device | Control group |
| Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS)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. | Device | Group that experience lower sodium intake |
Primary outcome
Part 1:Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community
Time frame: Baseline
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.
Part 2: Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community (canteen staff)
Time frame: baseline
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.
Part 3 Study A: Interventional study on salt and sugar reduction of selected foods sold on campus (students and staff )
Time frame: baseline and 3 months after invention
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.
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Blood Pressure)
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
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)
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Wasit to Hip ratio)
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
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
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)
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
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
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Fats)
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
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%
Part 3 Study B: Anthropometric and body composition measurements of salt and sugar reduction of selected foods sold on campus (Resting Metabolic Rate)
Time frame: at three timepoints - at the start of the study, after 3 months and after 6 months
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)
4 secondary outcomes
Part 3 Study B: Assessment of saltiness intensity perception
Time frame: baseline and 3 months after invention
Part 3 Study B: Assessment of pleasantness
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
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
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 40690753Chia YC, Say YH, Cheng MH, Chung FFL, Lau TP, Ooi PB. Reduction of Salt and Sugar Contents in Canteen Foods and Intakes By Students and Staff at a Malaysian Higher Education Institution: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2025 Jul 21;14:e69610. doi: 10.2196/69610.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yook Chia Chin, MD principal investigator
Sunway University
Questions about this trial
What is this clinical trial studying?
A study testing Reduction in Salt and Sugar, The potentiometer and Dry Ashing Method Followed by Flame Atomic Absorption Spectrometry (FAAS) in people with Cardiovascular Diseases, run by Sunway University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yook Chin Chia, MD (+60 12-273 9366, ycchia@sunway.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1:Knowledge, Attitude, and Practice (KAP) on dietary salt and sugar intake among Sunway University and Sunway College community (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06473038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.