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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.
Full 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.
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Inclusion criteria
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:
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:
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 purpose
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Interventional model
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201 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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