The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C

NCT ID: NCT02881658

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-02-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Plant sterols-enriched 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).

Group Type: EXPERIMENTAL

Plant sterols-enriched soya beverage provided by Vitasoy

Intervention Type: DIETARY_SUPPLEMENT

the study product is a 2g plant sterols-enriched in 250ml soya beverage

Soya beverage provided by Vitasoy

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).

Group Type: PLACEBO_COMPARATOR

Soya beverage provided by Vitasoy

Intervention Type: DIETARY_SUPPLEMENT

the placebo product is a 250 ml soya beverage

Interventions

Plant sterols-enriched soya beverage provided by Vitasoy

the study product is a 2g plant sterols-enriched in 250ml soya beverage

Intervention Type: DIETARY_SUPPLEMENT

Soya beverage provided by Vitasoy

the placebo product is a 250 ml soya beverage

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Professor Bernard Cheung

Professor of Department of Medicine, HKU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernard Man Yung Cheung

Role: PRINCIPAL_INVESTIGATOR

Li Ka Shing Faculty of Medicine, The University of Hong Kong

Locations

Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Chau YP, Cheng YC, Sing CW, Tsoi MF, Cheng VK, Lee GK, Cheung CL, Cheung BMY. The lipid-lowering effect of once-daily soya drink fortified with phytosterols in normocholesterolaemic Chinese: a double-blind randomized controlled trial. Eur J Nutr. 2020 Sep;59(6):2739-2746. doi: 10.1007/s00394-019-02119-w. Epub 2019 Oct 23.

Reference Type: DERIVED

PMID: 31642984 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CTC1521

Identifier Type: -

Identifier Source: org_study_id