Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

NCT03723330 | Completed

• 1 other identifier: S6
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Endothelial Dysfunction; Metabolic Syndrome; Diet Modification

Keywords

Endothelial function; Blood pressure; healthy diet

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Change in blood lipid-lipoproteins

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

• Change in skin carotenoid status

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

• Height

  Pre-intervention only

• Change in weight

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

• Change in waist circumference

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

Study Arms (2)

Plant sterol with a healthy diet

EXPERIMENTAL

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; Other: healthy diet

Healthy diet

ACTIVE COMPARATOR

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

Interventions

plant sterols DIETARY_SUPPLEMENT

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

Plant sterol with a healthy diet

healthy diet OTHER

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

Healthy diet; Plant sterol with a healthy diet

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, 117543, Singapore

Location

Related Publications (2)

• 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.

  PMID: 28708316 BACKGROUND

• Xu Y, Sutanto CN, Xia X, Toh DWK, Gan AX, Deng Q, Ling LH, Khoo CM, Foo RS, Kim JE. Consumption of plant sterols-enriched soy milk with a healthy dietary pattern diet lowers blood pressure in adults with metabolic syndrome: A randomized controlled trial. Nutr Metab Cardiovasc Dis. 2025 Jan;35(1):103773. doi: 10.1016/j.numecd.2024.10.011. Epub 2024 Oct 16.

  PMID: 39561689 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Metabolic Syndrome

Interventions

Phytosterols; Diet, Healthy

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sterols; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Membrane Lipids; Lipids; Phytochemicals; Biological Factors; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• J Eun Kim, PhD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 29, 2018
• Study Start: December 9, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)