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The lipid-lowering effect of once-daily soya drink fortified with phytosterols in normocholesterolaemic Chinese: a double-blind randomized controlled trial

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Abstract

Purpose

Phytosterols reduce intestinal cholesterol absorption and help to lower LDL-cholesterol. Many Chinese adults are lactose-intolerant and cannot tolerate bovine milk enriched with phytosterol. Soya-milk is a common beverage in Asia and it has beneficial effects on general health. We therefore conducted a randomized double-blind controlled trial to assess the effectiveness of a phytosterols-enriched soya drink in lowering serum LDL-cholesterol level (primary outcome) and other cardiovascular parameters (secondary outcomes).

Methods

One hundred and fifty-nine normocholesterolaemic participants (85 men and 74 women; aged 19–79) were randomized to daily intake of one serving of phytosterols-enriched soya drink (N = 82), equivalent to 2 g of phytosterol per day, or a matched soya drink without phytosterols (N = 77) for 3 weeks. Adverse events, withdrawal and compliance were documented.

Results

Among the treatment group (N = 82), phytosterols-enriched soya drink significantly decreased LDL-cholesterol by 5.96% (SE 1.48, 95% CI − 8.91%, − 3.00%) with a median of 6.74% compared with baseline, resulting in a significant reduction of 4.70% (95% CI − 8.89%, − 0.51%; p = 0.028) with a median of 5.20% compared with placebo (N = 77). In contrast, there were no significant changes in other lipid parameters, blood glucose, blood pressure, body weight or waist circumference. Remarkably, 95% of the participants randomized to the fortified drink reported no adverse events at all.

Conclusions

Daily consumption of a phytosterols-enriched soya drink may be a simple and cost-neutral means of lowering LDL-cholesterol in individuals in China, with massive population and rising incidence of coronary heart disease (ClinicalTrials.gov identifier: NCT02881658; date of registration: 14 Aug 2016).

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Author information

Author notes

  1. Yin-Pan Chau and Yu-Chun Cheng contributed equally.

Authors and Affiliations

  1. Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Sassoon Road, Pokfulam, Hong Kong

    Yin-Pan Chau, Yu-Chun Cheng, Chor-Wing Sing, Vincent Ka-Fai Cheng, Grace Koon-Yee Lee & Ching-Lung Cheung

  2. Department of Medicine, Faculty of Medicine, Queen Mary Hospital, The University of Hong Kong, 102 Pokfulam Road, Pokfulam, Hong Kong

    Man-Fung Tsoi, Ching-Lung Cheung & Bernard M. Y. Cheung

  3. Centre for Genomic Sciences, Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong

    Ching-Lung Cheung & Bernard M. Y. Cheung

  4. State Key Laboratory of Pharmaceutical Biotechnology, Faculty of Medicine, The University of Hong Kong, Pokfulam, Hong Kong

    Ching-Lung Cheung & Bernard M. Y. Cheung

Authors
  1. Yin-Pan Chau
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Contributions

BMYC and CLC designed the study, interpreted the data and wrote the first draft. YPC, YCC, CWS, MFT, VKFC, GKYL were involved in subject enrollment, subject interview and performing physical assessments, BMYC and CLC supervised the whole RCT. All authors have read and approved the final version of the manuscript and its conclusions. The corresponding authors had full access to the data and had final responsibility for the decision to submit for publication.

Corresponding authors

Correspondence to Ching-Lung Cheung or Bernard M. Y. Cheung.

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Conflict of interest

Yes, there is potential competing interest. All authors declare: grants from The University of Hong Kong, sponsorship from Vitasoy International Holdings Ltd. for the study.

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Chau, YP., Cheng, YC., Sing, CW. et al. The lipid-lowering effect of once-daily soya drink fortified with phytosterols in normocholesterolaemic Chinese: a double-blind randomized controlled trial. Eur J Nutr 59, 2739–2746 (2020). https://doi.org/10.1007/s00394-019-02119-w

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  • DOI: https://doi.org/10.1007/s00394-019-02119-w

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