NCT03723330

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-09
• Primary completion: 2021-05-31
• Completion: 2021-05-31
• First posted: 2018-10-29
• Last updated: 2021-09-08

Locations

1 site across 1 country: Singapore