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N/A Completed N=201 Randomized Triple-blind Treatment

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

Source: ClinicalTrials.gov NCT02881658 ↗
Enrolled (actual)
201
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3 — 2.91; 2.83; 2.71; 2.75 mmol/L

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean of Serum Low-density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
2.91; 2.83; 2.71; 2.75 —
SECONDARY
Change of Low Density Lipoprotein Cholesterol (LDL-C) Via Blood Test at Baseline and Week 3
-7.69; -1.56 —
SECONDARY
Change of High-density Lipoprotein Cholesterol (HDL-C) Via Blood Test at Baseline and Week 3
0.0; 0.0 —
SECONDARY
Change of Total Cholesterol Via Blood Test at Baseline and Week 3
-2.82; -1.86 —
SECONDARY
Change of Triglycerides (TAG) Via Blood Test at Baseline and Week 3
0.00; -1.88 —
SECONDARY
Change of Serum Creatinine Via Blood Test at Baseline and Week 3
0; 0 —
SECONDARY
Changes of Fasting Blood Glucose Via Blood Test at Baseline and Week 3
0.0; 0.0 —
SECONDARY
Changes of Cardiometabolic Risk Factors Via Measuring Anthropometry at Baseline and Week 3
-0.1; 0.2; 0; 0; 0; 0 —
SECONDARY
Changes of Cardiometabolic Risk Factors Via Measuring Blood Pressure at Baseline and Week 3
-1; -2; -3; -3 —
SECONDARY
Changes of Cardiometabolic Risk Factors Via Measuring Body Temperature at Baseline and Week 3
-0.3; -0.3 —
SECONDARY
Changes of Musculoskeletal-related Traits Via Measuring Hand Grip Strength at Baseline and Week 3
2; 0 —
SECONDARY
Changes of Musculoskeletal-related Traits Via Measuring Bio-Impedance at Baseline and Week 3
-1.0; -0.8; -1.1; -0.7 —
SECONDARY
Changes of Musculoskeletal-related Traits Via Measuring Peak Expiratory Flow Rate at Baseline and Week 3
0; -0 —
SECONDARY
Changes of Musculoskeletal-related Traits Via Measuring 6 Metres Gait Speed at Baseline and Week 3
-1.74; -1.46 —
SECONDARY
Changes of Musculoskeletal-related Traits Via Measuring Centre of Pressure Excursion Index for Left and Right Foot at Baseline and Week 3
0; 0; 4; -5 —

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02881658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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