Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| plant sterols | Dietary Supplement | Consumption a healthy eating pattern diet with a plant sterols-enriched food product |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in brachial artery flow-mediated dilation (FMD) | Brachial artery FMD will be measured by high-frequency and ultrasonographic imaging. | 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. | 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. | Every 4 weeks (Week 1, week 5, week 9, week 13) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Every 4 weeks (Week 1, week 5, week 9, week 13) |
| Change in skin carotenoid status |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J Eun Kim, PhD | National University of Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapore | Singapore | 117543 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28708316 | Background | 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. | |
| 39561689 | Derived | Xu 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. |
Not provided
Not provided
Electronic copies of the data with identifiable participant information will be kept, data will be de-identified prior to be statistical analysis.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010840 | Phytosterols |
| D000072001 | Diet, Healthy |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| healthy diet | Other | Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board. |
|
Measured using resonance Raman spectroscopy. |
| Every 4 weeks (Week 1, week 5, week 9, week 13) |
| Height | Height (cm) | Pre-intervention only |
| Change in weight | Weight (kg) | Every 4 weeks (Week 1, week 5, week 9, week 13) |
| Change in waist circumference | Waist circumference (cm) | Every 4 weeks (Week 1, week 5, week 9, week 13) |
| Change in diet | Dietary assessment, 3-day food record | 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) | Every 4 weeks (Week 1, week 5, week 9, week 13) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |