National University of Singapore
Singapore, 117543
NCT Number: NCT03723330
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.
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Notify Me35 year and older
All sexes
Interventional
Not applicable
Singapore, 117543
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consumption a healthy eating pattern diet with a plant sterols-enriched food product
Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.
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.
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.
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.
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Assessing the blood lipid-lipoproteins profile includes the measurements of plasma total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride concentrations.
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Measured using resonance Raman spectroscopy.
Time frame: Pre-intervention only
Height (cm)
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Weight (kg)
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Waist circumference (cm)
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
Dietary assessment, 3-day food record
Time frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
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)
National University of Singapore
Other
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
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