N/A
Completed N=201
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
| Outcome | Result | p-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.
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.