NCT02881658

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Plant sterols-enriched soya beverage provided by Vitasoy	the study product is a 2g plant sterols-enriched in 250ml soya beverage
DIETARY_SUPPLEMENT	Soya beverage provided by Vitasoy	the placebo product is a 250 ml soya beverage

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2016-08-29
• Last updated: 2018-05-03
• Results posted: 2017-09-21

Locations

1 site across 1 country: Hong Kong