Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723330
• Other study ID #: S6
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: August 2021
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diet Modification
• Endothelial Dysfunction
• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	Change in skin carotenoid status	Measured using resonance Raman spectroscopy.	Every 4 weeks (Week 1, week 5, week 9, week 13)
Secondary	Height	Height (cm)	Pre-intervention only
Secondary	Change in weight	Weight (kg)	Every 4 weeks (Week 1, week 5, week 9, week 13)
Secondary	Change in waist circumference	Waist circumference (cm)	Every 4 weeks (Week 1, week 5, week 9, week 13)
Secondary	Change in diet	Dietary assessment, 3-day food record	Every 4 weeks (Week 1, week 5, week 9, week 13)
Secondary	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)