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

Primary Purpose

Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Plant sterols-enriched soya beverage provided by Vitasoy
Soya beverage provided by Vitasoy
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols, Soya Beverage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Plant sterols-enriched soya beverage provided by Vitasoy

Soya beverage provided by Vitasoy

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3

Secondary Outcome Measures

Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
Change of Total Cholesterol Via Blood Test at Baseline and Week 3
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
Change of Serum Creatinine Via Blood Test at Baseline and Week 3
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and 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

Full Information

First Posted
August 14, 2016
Last Updated
May 2, 2018
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02881658
Brief Title
The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C
Official Title
The Effect of Soya Beverage Fortified With Plant Sterol on Major Serum Lipids in Normocholesterolemic, Healthy Southern Chinese Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia
Keywords
Plant sterols, Low-Density Lipoprotein Cholesterol, Phytosterols, Soya Beverage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plant sterols-enriched soya beverage provided by Vitasoy
Arm Type
Experimental
Arm Description
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).
Arm Title
Soya beverage provided by Vitasoy
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Plant sterols-enriched soya beverage provided by Vitasoy
Intervention Description
the study product is a 2g plant sterols-enriched in 250ml soya beverage
Intervention Type
Dietary Supplement
Intervention Name(s)
Soya beverage provided by Vitasoy
Intervention Description
the placebo product is a 250 ml soya beverage
Primary Outcome Measure Information:
Title
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Time Frame
From baseline to week 3
Secondary Outcome Measure Information:
Title
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Change of Total Cholesterol Via Blood Test at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Change of Serum Creatinine Via Blood Test at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3
Time Frame
From baseline to week 3
Title
Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3
Description
centre of pressure excursion index = CPEI
Time Frame
From baseline to week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernard Man Yung Cheung
Organizational Affiliation
Li Ka Shing Faculty of Medicine, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Ka Shing Faculty of Medicine, The University of Hong Kong, Pokfulam
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
31642984
Citation
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.
Results Reference
derived

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

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