Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Endothelial Dysfunction; Diet Modification; Metabolic Syndrome
• Interventions: Dietary Supplement: plant sterols; Other: healthy diet

• Registration Number: NCT03723330
• Lead Sponsor: National University of Singapore

Brief 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 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 Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Study Start: 2019-12-09
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Ability to give an informed consent;
2. Age>35 years old;
3. 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);
4. Weight change < 3kg in the past 3 months;
5. No exercising vigorously over the past 3 months;
6. No allergy to plant sterols; no acute illness; not smoking;
7. No drinking more than 2 alcoholic drinks per day;
8. No pregnant, lactating, or planning pregnancy in the next 6 months.

Exclusion Criteria

1. Unable to give an informed consent;
2. Age<35 years old;
3. 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);
4. Weight change > 3kg in the past 3 months;
5. Exercise vigorously over the past 3 months;
6. Allergy to plant sterols; no acute illness; not smoking;
7. Drinking more than 2 alcoholic drinks per day;
8. Pregnant, lactate, or plan pregnancy in the next 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Plant sterol with a healthy diet	plant sterols	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	healthy diet	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.
Plant sterol with a healthy diet	healthy diet	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).

Primary Outcome Measures

Name	Time	Method
Change in brachial artery flow-mediated dilation (FMD)	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in diet	Every 4 weeks (Week 1, week 5, week 9, week 13)	Dietary assessment, 3-day food record
Change in sleep quality (Pittsburgh sleep quality index questionnaire (PSQI))	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)
Change in skin carotenoid status	Every 4 weeks (Week 1, week 5, week 9, week 13)	Measured using resonance Raman spectroscopy.
Change in weight	Every 4 weeks (Week 1, week 5, week 9, week 13)	Weight (kg)
Change in waist circumference	Every 4 weeks (Week 1, week 5, week 9, week 13)	Waist circumference (cm)
Change in blood lipid-lipoproteins	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.
Height	Pre-intervention only	Height (cm)

Trial Locations

Locations (1)

National University of Singapore; 🇸🇬 Singapore, Singapore