Clinical trial NCT02881658: The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C
Official title: The Effect of Soya Beverage Fortified With Plant Sterol on Major Serum Lipids in Normocholesterolemic, Healthy Southern Chinese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyslipidemia
Keywords: Plant sterols
Low-Density Lipoprotein Cholesterol
Phytosterols
Soya Beverage
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
timeFrame: From baseline to week 3
Secondary outcomes:
measure: Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Change of Total Cholesterol Via Blood Test at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Change of Serum Creatinine Via Blood Test at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3
timeFrame: From baseline to week 3
measure: Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3
timeFrame: From baseline to week 3
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam
Study officials:
affiliation: Li Ka Shing Faculty of Medicine, The University of Hong Kong
name: Bernard Man Yung Cheung
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.