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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant sterols-enriched soya beverage provided by Vitasoy | Experimental | 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). |
|
| Soya beverage provided by Vitasoy | Placebo Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant sterols-enriched soya beverage provided by Vitasoy | Dietary Supplement | the study product is a 2g plant sterols-enriched in 250ml soya beverage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3 | From baseline to week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3 | From baseline to week 3 | |
| Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3 | From baseline to week 3 |
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Inclusion Criteria:
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Man Yung Cheung | Li Ka Shing Faculty of Medicine, The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam | Hong Kong | Hong Kong |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31642984 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3 | All 201 subjects were included in the population, but certain blood test result on LDL-C were not available, thus difference in the overall number of participants analyzed and the actual number of participants included to present the mean value. | Posted | Mean | Standard Deviation | mmol/L | From baseline to week 3 |
|
Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plant Sterols-enriched Soya Beverage | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Cheung Ching Lung | The University of Hong Kong | (852)28315085 | lung1212@hku.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 17, 2016 | Aug 24, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Soya beverage provided by Vitasoy | Dietary Supplement | the placebo product is a 250 ml soya beverage |
|
| 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 |
| Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure 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 | centre of pressure excursion index = CPEI | From baseline to week 3 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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 |
|
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| Secondary | Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Change of Total Cholesterol Via Blood Test at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Change of Serum Creatinine Via Blood Test at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of body temperature change | From baseline to week 3 |
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| Secondary | Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3 | Posted | Median | Inter-Quartile Range | percentage of change | From baseline to week 3 |
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| Secondary | Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3 | centre of pressure excursion index = CPEI | Posted | Median | Inter-Quartile Range | Percentage of Change | From baseline to week 3 |
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| 0 |
| 100 |
| 0 |
| 100 |
| 5 |
| 100 |
| EG001 | Soya Beverage | 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 | 0 | 101 | 0 | 101 | 1 | 101 |
| Stomach Bloating | Gastrointestinal disorders | Systematic Assessment |
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| Slight hardening of stool during the three weeks period | Gastrointestinal disorders | Systematic Assessment |
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| Flu | Infections and infestations | Systematic Assessment |
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| Median percentage change of Hip circumference |
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