The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C
Dyslipidemia
About this trial
This is an interventional treatment trial for Dyslipidemia focused on measuring Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols, Soya Beverage
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.
Sites / Locations
- Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Plant sterols-enriched soya beverage provided by Vitasoy
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).
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).