The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C

The Effect of Soya Beverage Fortified With Plant Sterol on Major Serum Lipids in Normocholesterolemic, Healthy Southern Chinese Individuals

This is a local, single-center, two-arm, randomized, double-blind, placebo-controlled clinical trial that examines the LDL-C-lowering effect of the consumption of a soya beverage enriched with plant sterol for 3 weeks. This study also examines if there is other health-benefits by consuming the plant sterols fortified soya beverage in terms of serum total triglyceride, total and HDL cholesterol, other cardiometabolic risk factors and musculoskeletal-related traits including handgrip strength, gait speed, peak expiratory flow rate, bio-impedance and body balance.

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Dietary supplement: Plant sterols-enriched soya beverage provided by Vitasoy; Dietary supplement: Soya beverage provided by Vitasoy

Detailed Description

Cardiovascular disease (CVD) is the third commonest cause of deaths in Hong Kong and accounting for 14.4% of all deaths in 2012. Robust data attest the causal role of low-density lipoprotein cholesterol (LDL-C) in the development and progression of CVD. Reduction of LDL-C levels achieved by pharmacological agents in conjunction with diet change has been demonstrated to significantly reduce CVD morbidity and mortality. Moreover, it has been frequently reported that dietary incorporation of plant sterols/stanols could reduce blood LDL-C level in both healthy and dyslipidaemic individuals with great inter-individual variability of LDL-C response. Therefore, functional food enriched with plant sterols/stanols not only may provide additional LDL-C lowering benefit in dyslipidaemic patients as an adjunct to traditional pharmacologic therapy, but also play a role in primary prevention of CVD in the general population.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Southern Chinese male or female ≥ 18 years;
• In good general health as evidenced by medical history;
• Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclose of research-related health information, and comply with the study data collection procedures. Provide signed and dated informed consent form

Exclusion Criteria:

• Subject with familial hypercholesterolemia;

• On regular medication(s) which affect gastrointestinal functions and blood lipids level for the past 3 months, such as, but not limited to:

  • Antibiotics of >1 week duration
  • GI related medications such as antacids
• Having blood lipid lowering medications such as statins, selective cholesterol absorption inhibitors (e.g. ezetimibe), fibrates, niacin, resins, omega- 3
• Heavy-smokers (more than 1 pack per day)
• Subject with heavy alcohol intake (>40 g/day for men ; >30 g/day for women) (32), or having history of alcohol abuse within 12 months prior to the study
• Subjects with taste aversion to placebo/intervention soya beverages

• Subject refusing to stop the consumption of plant sterols-enriched products if any during the study (other than the studied product) or having regular consumption of sterols/stanols cholesterol-lowering supplements/functional foods or other related products such as:

  • Sterol/ Stanol - containing margarines, milk, yoghurt drink and soya beverages
  • Sterol / Stanol supplements
  • Fish oils & omega-3 supplements
• Subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters
• Subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial
• Pregnancy or lactation
• Having soy allergy
• Being a vegan
• Being an athlete
• Concurrently participating in weight management or dietary program
• On diet pills, such as, but not limited to chitosan and dulcolax
• With history of sitosterolemia
• Having history of hypercholesterolemia, diabetes, thyroid disease, severe kidney diseases, cardiovascular diseases, chronic gastrointestinal disorders, cancers and AIDs ( acquired immune deficiency syndrome)
• Having history of malabsorption syndrome arising from diseases such as, but not limited to celiac disease, short bowel syndrome, cystic fibrosis, pancreatitis, diseases of gall-bladder, liver or pancreas, intestinal infection, injury, surgery and radiotherapy
• Taking over-the-counter Chinese medications or supplements with cholesterol/lipid lowering and related claims
• High blood cholesterol at screening [Total cholesterol level ≥6.22mmol/L]
• High LDL cholesterol [LDL cholesterol level ≥4.15mmol/L]
• High blood triglyceride at screening [Triglyceride ≥3.39mmol/L]
• Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Plant sterols-enriched soya beverage provided by Vitasoy; Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).	Dietary supplement: Plant sterols-enriched soya beverage provided by Vitasoy; the study product is a 2g plant sterols-enriched in 250ml soya beverage
PLACEBO_COMPARATOR: Soya beverage provided by Vitasoy; Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner).	Dietary supplement: Soya beverage provided by Vitasoy; the placebo product is a 250 ml soya beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3	From baseline to week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3		From baseline to week 3
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3		From baseline to week 3
Change of Total Cholesterol Via Blood Test at Baseline and Week 3		From baseline to week 3
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3		From baseline to week 3
Change of Serum Creatinine Via Blood Test at Baseline and Week 3		From baseline to week 3
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3		From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3		From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3		From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3		From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3		From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3		From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3		From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3		From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3	centre of pressure excursion index = CPEI	From baseline to week 3

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: Bernard Man Yung Cheung, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Publications and helpful links

General Publications

• Chau YP, Cheng YC, Sing CW, Tsoi MF, Cheng VK, Lee GK, Cheung CL, Cheung BMY. The lipid-lowering effect of once-daily soya drink fortified with phytosterols in normocholesterolaemic Chinese: a double-blind randomized controlled trial. Eur J Nutr. 2020 Sep;59(6):2739-2746. doi: 10.1007/s00394-019-02119-w. Epub 2019 Oct 23.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: August 14, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (ESTIMATE): August 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Phytosterols; Plant sterols; Low-Density Lipoprotein Cholesterol; Soya Beverage
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: CTC1521