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Completed

NCT Number: NCT03723330

Impact of Consuming Plant Sterols on Endothelial Function and Blood Pressure

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Singapore

Singapore, 117543

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plant Sterols

Dietary Supplement

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

healthy diet

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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 outcomes

  1. 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.

  2. Change in skin carotenoid status

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

    Measured using resonance Raman spectroscopy.

  3. Height

    Time frame: Pre-intervention only

    Height (cm)

  4. Change in weight

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

    Weight (kg)

  5. Change in waist circumference

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

    Waist circumference (cm)

  6. Change in diet

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

    Dietary assessment, 3-day food record

  7. 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)

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2018
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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