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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02881658

Enrollment

201

Registered

2016-08-29

Start date

2016-05-31

Completion date

2017-02-01

Last updated

2018-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia

Keywords

Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols, Soya Beverage

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.

Interventions

DIETARY_SUPPLEMENTPlant sterols-enriched soya beverage provided by Vitasoy

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

DIETARY_SUPPLEMENTSoya beverage provided by Vitasoy

the placebo product is a 250 ml soya beverage

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3	From baseline to week 3

Secondary

Measure	Time frame	Description
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3	From baseline to week 3	—
Change of Total Cholesterol Via Blood Test at Baseline and Week 3	From baseline to week 3	—
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3	From baseline to week 3	—
Change of Serum Creatinine Via Blood Test at Baseline and Week 3	From baseline to week 3	—
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3	From baseline to week 3	—
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3	From baseline to week 3	—
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3	From baseline to week 3	—
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3	From baseline to week 3	—
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3	From baseline to week 3	—
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3	From baseline to week 3	—
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3	From baseline to week 3	—
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3	From baseline to week 3	—
Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3	From baseline to week 3	centre of pressure excursion index = CPEI
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3	From baseline to week 3	—

Countries

Hong Kong

Participant flow

Participants by arm

Arm	Count
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). Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage	100
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). Soya beverage: the placebo product is a 250 ml soya beverage	101
Total	201

Baseline characteristics

Characteristic	Plant Sterols-enriched Soya Beverage Provided by Vitasoy	Soya Beverage Provided by Vitasoy	Total
Age, Continuous	46 years STANDARD_DEVIATION 16.5	44 years STANDARD_DEVIATION 16.7	45 years STANDARD_DEVIATION 16.6
Race and Ethnicity Not Collected	—	—	0 Participants
Sex: Female, Male Female	49 Participants	52 Participants	101 Participants
Sex: Female, Male Male	51 Participants	49 Participants	100 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 100	0 / 101
other Total, other adverse events	5 / 100	1 / 101
serious Total, serious adverse events	0 / 100	0 / 101