Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Metabolic Syndrome; Diet Modification; Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: plant sterols; Other: healthy diet

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117543
    • National University of Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Plant sterol with a 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).	Dietary supplement: plant sterols; Consumption a healthy eating pattern diet with a plant sterols-enriched food product; Other: healthy diet; Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.
ACTIVE_COMPARATOR: 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.	Other: healthy diet; Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: National University of Singapore
• Investigators: Principal Investigator: J Eun Kim, PhD, National University of Singapore

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 9, 2019
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: October 23, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (ACTUAL): October 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Endothelial function; Blood pressure; healthy diet
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: S6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Electronic copies of the data with identifiable participant information will be kept, data will be de-identified prior to be statistical analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No