Cardiovascular DiseasesNCT03723330
Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure
A study testing plant sterols and healthy diet in people with Cardiovascular Diseases and Endothelial Dysfunction, run by National University of Singapore at 1 site in Singapore.
Trial summary
The purpose of the research is to assess the impact of co-consuming plant sterols-enriched food product as part of a healthy eating pattern diet on endothelial function (brachial artery FMD, vasodilation-related and vasoconstriction-related biomarkers) and blood pressure management (24-hour ambulatory and classic… Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Endothelial Dysfunction, Metabolic Syndrome
- What is being tested?
- plant sterols and healthy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 9 Dec 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to give an informed consent;
- Age>35 years old;
- Meet any 3 of the 5 following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
- Weight change < 3kg in the past 3 months;
- No exercising vigorously over the past 3 months;
- No allergy to plant sterols; no acute illness; not smoking;
- No drinking more than 2 alcoholic drinks per day;
- No pregnant, lactating, or planning pregnancy in the next 6 months.
Who cannot join
- Unable to give an informed consent;
- Age<35 years old;
- Meet less than 3 of following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
- Weight change > 3kg in the past 3 months;
- Exercise vigorously over the past 3 months;
- Allergy to plant sterols; no acute illness; not smoking;
- Drinking more than 2 alcoholic drinks per day;
- Pregnant, lactate, or plan pregnancy in the next 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Co-consuming a Plant Sterols-enriched Food Product With a Healthy Eating Pattern Diet on Endothelial Function and Blood Pressure Management in Individuals With Metabolic Syndrome
The purpose of the research is to assess the impact of co-consuming plant sterols-enriched food product as part of a healthy eating pattern diet on endothelial function (brachial artery FMD, vasodilation-related and vasoconstriction-related biomarkers) and blood pressure management (24-hour ambulatory and classic blood pressure) in Singapore individuals with MetS.
Read the detailed description
This is a 13-wk double-blinded, randomized, crossover study design. Following a 1-wk pre-intervention baseline period, subjects will be randomly assigned to follow a healthy eating pattern diet either contain 2.0 g free plant sterols equivalent of their palmityl esters (Plant Sterol Diet) or do not contain plant sterols (Control Diet) for 4 weeks. After a 4-week dietary 'washout' period, they will consume the alternative diet for 4 weeks. The random assignment will be done with SAS 9.4 software. Body size measurement, dietary assessment, brachial artery FMD and blood pressure measurements, and fasting-state blood collection will be conducted at week 1, 5, 9, and 13, which correspond to before and during the last 1 week of the two 4-week intervention periods.
During study week 1 and weeks 6-9, all subjects will consume their habitual, unrestricted self-chosen diets. During study weeks 2-5 and 10-13, all subject will follow a healthy eating pattern diet, referred to as the "My Healthy Plate" designed by HPB. Each subject's energy requirement will be estimated using sex-specific equations and Recommended Dietary Allowances for healthy Singaporean. One-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff to achieve a healthy eating pattern diet. Compliance with the plant sterols consumption will be promoted by frequent online and in-person contact.
- Being tested
- plant sterols, healthy diet
- Keywords
- Endothelial function, Blood pressure, healthy diet
- Medical subject headings
- Cardiovascular Diseases, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plant sterolsDietary supplement
Consumption a healthy eating pattern diet with a plant sterols-enriched food product
healthy dietOther
Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.
| Study group | Role | What they receive |
|---|---|---|
| Plant sterol with a healthy diet | Experimental | Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided with specific instructions to consume plant sterols-enriched food (contains 2 g plant sterols). Receives: Dietary Supplement: plant sterols; Other: healthy diet |
| Healthy diet | Active comparator | Each subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Receives: Other: healthy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brachial artery flow-mediated dilation (FMD)
Brachial artery FMD will be measured by high-frequency and ultrasonographic imaging.
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in vasodilation and vasoconstriction related biomarkers
Vasodilation and vasoconstriction related biomarkers contains nitric oxide, endothelial nitric oxide synthase, and endothelin-1. They will be measured using the commercially available ELISA assay kits.
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in blood pressure
Classical and 24-hour ambulatory blood pressure: Systolic and diastolic blood pressure and 5-day of 24-hour ambulatory blood pressure will be measured.
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Secondary outcomes (7)
Change in blood lipid-lipoproteins
Assessing the blood lipid-lipoproteins profile includes the measurements of plasma total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride concentrations.
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in skin carotenoid status
Measured using resonance Raman spectroscopy.
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Height
Height (cm)
Measured: Pre-intervention only
Change in weight
Weight (kg)
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in waist circumference
Waist circumference (cm)
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in diet
Dietary assessment, 3-day food record
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in sleep quality (Pittsburgh sleep quality index questionnaire (PSQI))
Recall based questionnaire assessing sleep habits for the past one month only which includes sleeping timing habits and quality of sleep (Very good, Fairly good, Fairly bad and very bad)
Measured: Every 4 weeks (Week 1, week 5, week 9, week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start9 Dec 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Eun Kim, National University of Singapore
- Investigators
- J Eun Kim, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723330
- Sponsor's protocol ID
- S6
- Status last verified
- Aug 2021
- First submitted
- 23 Oct 2018
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Electronic copies of the data with identifiable participant information will be kept, data will be de-identified prior to be statistical analysis.
Publications
Ho XL, Loke WM. Dietary Plant Sterols Supplementation Increases In Vivo Nitrite and Nitrate Production in Healthy Adults: A Randomized, Controlled Study. J Food Sci. 2017 Jul;82(7):1750-1756. doi: 10.1111/1750-3841.13752.
PubMed 28708316Xu Y, Sutanto CN, Xia X, Toh DWK, Gan AX, Deng Q, Ling LH, Khoo CM, Foo RS, Kim JE. Consumption of plant sterols-enriched soy milk with a healthy dietary pattern diet lowers blood pressure in adults with metabolic syndrome: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2025 Jan;35(1):103773. doi: 10.1016/j.numecd.2024.10.011. Epub 2024 Oct 16.
PubMed 39561689
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Co-consuming a Plant Sterols-enriched Food Product With a Healthy Eating Pattern Diet on Endothelial Function and Blood Pressure Management in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03723330
- Acronym / sponsor ID
- S6
- Keywords
- Endothelial function, Blood pressure, healthy diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Oct 2018 (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.
The purpose of the research is to assess the impact of co-consuming plant sterols-enriched food product as part of a healthy eating pattern diet on endothelial function (brachial artery FMD, vasodilation-related and vasoconstriction-related biomarkers) and blood pressure management (24-hour ambulatory and classic blood pressure) in Singapore individuals with MetS.
Detailed description
This is a 13-wk double-blinded, randomized, crossover study design. Following a 1-wk pre-intervention baseline period, subjects will be randomly assigned to follow a healthy eating pattern diet either contain 2.0 g free plant sterols equivalent of their palmityl esters (Plant Sterol Diet) or do not contain plant sterols (Control Diet) for 4 weeks. After a 4-week dietary 'washout' period, they will consume the alternative diet for 4 weeks. The random assignment will be done with SAS 9.4 software. Body size measurement, dietary assessment, brachial artery FMD and blood pressure measurements, and fasting-state blood collection will be conducted at week 1, 5, 9, and 13, which correspond to before and during the last 1 week of the two 4-week intervention periods.
During study week 1 and weeks 6-9, all subjects will consume their habitual, unrestricted self-chosen diets. During study weeks 2-5 and 10-13, all subject will follow a healthy eating pattern diet, referred to as the "My Healthy Plate" designed by HPB. Each subject's energy requirement will be estimated using sex-specific equations and Recommended Dietary Allowances for healthy Singaporean. One-on-one dietary counselling and written instructions for each subject will be provided by a research dietitian and trained research staff to achieve a healthy eating pattern diet. Compliance with the plant sterols consumption will be promoted by frequent online and in-person contact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant sterol with a healthy diet | Experimental | Dietary Supplement: plant sterols, Other: healthy dietEach subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. Subjects will also be provided with specific instructions to consume plant sterols-enriched food (contains 2 g plant sterols). |
| Healthy diet | Active comparator | Other: healthy dietEach subject will be provided one-to-one dietary counselling by a research dietitian and an instruction sheet to achieve the healthy eating pattern diet. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to give an informed consent;
- Age>35 years old;
- Meet any 3 of the 5 following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
- Weight change < 3kg in the past 3 months;
- No exercising vigorously over the past 3 months;
Key exclusion criteria (8 listed)
- Unable to give an informed consent;
- Age<35 years old;
- Meet less than 3 of following NCEP-ATP III MetS criteria (waist circumference > 90 cm (male), > 80 cm (female); fasting glucose concentration ≥ 100 mg/dL or on medication; triglyceride ≥ 150 mg/dL or on medication; high density lipoprotein cholesterol (HDL) < 40 mg/dL (male), < 50 mg/dL (female); systolic or diastolic blood pressure > 130/80 mmHg or on medication);
- Weight change > 3kg in the past 3 months;
- Exercise vigorously over the past 3 months;
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 |
|---|---|---|
| plant sterolsConsumption a healthy eating pattern diet with a plant sterols-enriched food product | Dietary supplement | Plant sterol with a healthy diet |
| healthy dietCompliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board. | Other | Healthy diet, Plant sterol with a healthy diet |
Primary outcome
Change in brachial artery flow-mediated dilation (FMD)
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Brachial artery FMD will be measured by high-frequency and ultrasonographic imaging.
Change in vasodilation and vasoconstriction related biomarkers
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Vasodilation and vasoconstriction related biomarkers contains nitric oxide, endothelial nitric oxide synthase, and endothelin-1. They will be measured using the commercially available ELISA assay kits.
Change in blood pressure
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Classical and 24-hour ambulatory blood pressure: Systolic and diastolic blood pressure and 5-day of 24-hour ambulatory blood pressure will be measured.
7 secondary outcomes
Change in blood lipid-lipoproteins
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in skin carotenoid status
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Height
Time frame: Pre-intervention only
Change in weight
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in waist circumference
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in diet
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Change in sleep quality (Pittsburgh sleep quality index questionnaire (PSQI))
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 28708316Ho XL, Loke WM. Dietary Plant Sterols Supplementation Increases In Vivo Nitrite and Nitrate Production in Healthy Adults: A Randomized, Controlled Study. J Food Sci. 2017 Jul;82(7):1750-1756. doi: 10.1111/1750-3841.13752.
- Derived from this study: PubMed 39561689Xu Y, Sutanto CN, Xia X, Toh DWK, Gan AX, Deng Q, Ling LH, Khoo CM, Foo RS, Kim JE. Consumption of plant sterols-enriched soy milk with a healthy dietary pattern diet lowers blood pressure in adults with metabolic syndrome: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2025 Jan;35(1):103773. doi: 10.1016/j.numecd.2024.10.011. Epub 2024 Oct 16.
- Individual participant dataSharing planned: No. Electronic copies of the data with identifiable participant information will be kept, data will be de-identified prior to be statistical analysis.
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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. This study is not recruiting at the moment.
J Eun Kim, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plant sterols and healthy diet in people with Cardiovascular Diseases and Endothelial Dysfunction, run by National University of Singapore at 1 site in Singapore.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in brachial artery flow-mediated dilation (FMD) (time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)). The study lists 3 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 NCT03723330, which also lists 2 linked publications.
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 8 Sep 2021.