DyslipidemiaNCT02881658
The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C
A study testing Plant sterols-enriched soya beverage provided by Vitasoy and Soya beverage provided by Vitasoy in people with Dyslipidemia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Plant sterols-enriched soya beverage provided by Vitasoy and Soya beverage provided by Vitasoy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2016to 1 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 28Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam
Hong Kong
About this study
Official title: The Effect of Soya Beverage Fortified With Plant Sterol on Major Serum Lipids in Normocholesterolemic, Healthy Southern Chinese Individuals
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.
Read the 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
- Being tested
- Plant sterols-enriched soya beverage provided by Vitasoy, Soya beverage provided by Vitasoy
- Keywords
- Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols, Soya Beverage
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plant sterols-enriched soya beverage provided by VitasoyDietary supplement
the study product is a 2g plant sterols-enriched in 250ml soya beverage
Soya beverage provided by VitasoyDietary supplement
the placebo product is a 250 ml soya beverage
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Dietary Supplement: Plant sterols-enriched soya beverage provided by Vitasoy |
| 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). Receives: Dietary Supplement: Soya beverage provided by Vitasoy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Measured: From baseline to week 3
Secondary outcomes (14)
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Measured: From baseline to week 3
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
Measured: From baseline to week 3
Change of Total Cholesterol Via Blood Test at Baseline and Week 3
Measured: From baseline to week 3
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
Measured: From baseline to week 3
Change of Serum Creatinine Via Blood Test at Baseline and Week 3
Measured: From baseline to week 3
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
Measured: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Measured: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
Measured: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
Measured: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
Measured: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
Measured: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
Measured: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3
Measured: 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
Measured: From baseline to week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startMay 2016
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Bernard Cheung, The University of Hong Kong
- Investigators
- Bernard Man Yung Cheung, Principal investigator, Li Ka Shing Faculty of Medicine, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881658
- Sponsor's protocol ID
- CTC1521
- Status last verified
- May 2018
- First submitted
- 14 Aug 2016
- Last updated
- 3 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31642984
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soya Beverage Fortified With Plant Sterol on Major Serum Lipids in Normocholesterolemic, Healthy Southern Chinese Individuals
- ClinicalTrials.gov ID
- NCT02881658
- Acronym / sponsor ID
- CTC1521
- Conditions
- Dyslipidemia
- Keywords
- Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols, Soya Beverage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Posted 21 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plant sterols-enriched soya beverage provided by Vitasoy | Experimental | Dietary Supplement: Plant sterols-enriched soya beverage provided by VitasoyDaily 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 | Dietary Supplement: Soya beverage provided by VitasoyDaily 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plant sterols-enriched soya beverage provided by Vitasoythe study product is a 2g plant sterols-enriched in 250ml soya beverage | Dietary supplement | Plant sterols-enriched soya beverage provided by Vitasoy |
| Soya beverage provided by Vitasoythe placebo product is a 250 ml soya beverage | Dietary supplement | Soya beverage provided by Vitasoy |
Primary outcome
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
14 secondary outcomes
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of Total Cholesterol Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Change of Serum Creatinine Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
Time frame: From baseline to week 3
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3
Time frame: 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
Time frame: From baseline to week 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31642984Chau 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Man Yung Cheung principal investigator
Li Ka Shing Faculty of Medicine, The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant sterols-enriched soya beverage provided by Vitasoy and Soya beverage provided by Vitasoy in people with Dyslipidemia, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3 (time frame: From baseline to week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02881658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.