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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
201
the study product is a 2g plant sterols-enriched in 250ml soya beverage
the placebo product is a 250 ml soya beverage
Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam
Hong Kong, Hong Kong
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of Total Cholesterol Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of Serum Creatinine Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
Time frame: From baseline to week 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3
Time frame: 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
Time frame: From baseline to week 3