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Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

Primary Purpose

Cardiovascular Diseases, Endothelial Dysfunction, Metabolic Syndrome

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

plant sterols

healthy diet

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Endothelial function, Blood pressure, healthy diet

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

National University of Singapore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Plant sterol with a healthy diet

Healthy diet

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in brachial artery flow-mediated dilation (FMD)

Brachial artery FMD will be measured by high-frequency and ultrasonographic imaging.

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.

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.

Secondary Outcome Measures

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.

Change in skin carotenoid status

Measured using resonance Raman spectroscopy.

Height

Height (cm)

Change in weight

Weight (kg)

Change in waist circumference

Waist circumference (cm)

Change in diet

Dietary assessment, 3-day food record

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)

Full Information

NCT ID

NCT03723330

First Posted

October 23, 2018

Last Updated

August 31, 2021

Sponsor

National University of Singapore

1. Study Identification

Unique Protocol Identification Number

NCT03723330

Brief Title

Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

December 9, 2019 (Actual)

Primary Completion Date

May 31, 2021 (Actual)

Study Completion Date

May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National University of Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases, Endothelial Dysfunction, Metabolic Syndrome, Diet Modification

Keywords

Endothelial function, Blood pressure, healthy diet

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Plant sterol with a healthy diet

Arm Type

Experimental

Arm Description

Arm Title

Healthy diet

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

plant sterols

Intervention Description

Consumption a healthy eating pattern diet with a plant sterols-enriched food product

Intervention Type

Other

Intervention Name(s)

healthy diet

Intervention Description

Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.

Primary Outcome Measure Information:

Title

Change in brachial artery flow-mediated dilation (FMD)

Description

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)

Title

Change in vasodilation and vasoconstriction related biomarkers

Description

Time Frame

Every 4 weeks (Week 1, week 5, week 9, week 13)

Title

Change in blood pressure

Description

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)

Secondary Outcome Measure Information:

Title

Change in blood lipid-lipoproteins

Description

Time Frame

Every 4 weeks (Week 1, week 5, week 9, week 13)

Title

Change in skin carotenoid status

Description

Measured using resonance Raman spectroscopy.

Time Frame

Every 4 weeks (Week 1, week 5, week 9, week 13)

Title

Height

Description

Height (cm)

Time Frame

Pre-intervention only

Title

Change in weight

Description

Weight (kg)

Time Frame

Every 4 weeks (Week 1, week 5, week 9, week 13)

Title

Change in waist circumference

Description

Waist circumference (cm)

Time Frame

Every 4 weeks (Week 1, week 5, week 9, week 13)

Title

Change in diet

Description

Dietary assessment, 3-day food record

Time Frame

Every 4 weeks (Week 1, week 5, week 9, week 13)

Title

Change in sleep quality (Pittsburgh sleep quality index questionnaire (PSQI))

Description

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)

Time Frame

Every 4 weeks (Week 1, week 5, week 9, week 13)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J Eun Kim, PhD

Organizational Affiliation

National University of Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

National University of Singapore

City

Singapore

ZIP/Postal Code

117543

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Electronic copies of the data with identifiable participant information will be kept, data will be de-identified prior to be statistical analysis.

Citations:

PubMed Identifier

28708316

Citation

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.

Results Reference

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Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

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