Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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).
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Change in brachial artery flow-mediated dilation (FMD)
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • Brachial artery FMD will be measured by high-frequency and ultrasonographic imaging.
  • Change in vasodilation and vasoconstriction related biomarkers
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • 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
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • 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 Measures

  • Change in blood lipid-lipoproteins
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • 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
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • Measured using resonance Raman spectroscopy.
  • Height
    • Time Frame: Pre-intervention only
    • Height (cm)
  • Change in weight
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • Weight (kg)
  • Change in waist circumference
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • Waist circumference (cm)
  • Change in diet
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • Dietary assessment, 3-day food record
  • Change in sleep quality (Pittsburgh sleep quality index questionnaire (PSQI))
    • Time Frame: Every 4 weeks (Week 1, week 5, week 9, week 13)
    • 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National University of Singapore
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jung Eun Kim, Assistant Professor – National University of Singapore
  • Overall Official(s)
    • J Eun Kim, PhD, Principal Investigator, National University of Singapore

References

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.

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