A Phase 2 interventional study of Synbiotic (LAB12 and SWEOAT® Bran) and Oat-based Placebo in Dyslipidemia, sponsored by Universiti Teknologi Mara. Not yet recruiting at 1 site in Malaysia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Universiti Teknologi Mara · Phase 2, Interventional, and Treatment
This 12-week randomized study investigates the effects of a synbiotic supplement (LAB12-G, combining oat-derived β-glucan and L. plantarum LAB12) on individuals with dyslipidemia who are currently on statin therapy. Participants will be assigned to either the LAB12-G treatment group or a placebo group receiving a β-glucan-free oat-based product. Both groups will consume two sachets of their assigned product daily by mixing with 200 mL of water during breakfast and dinner. Participants are required to continue all their medications including the statins throughout the whole study. The primary objectives are to evaluate whether this synbiotic combination improves cholesterol levels and gut microbiota composition when used alongside standard statin treatment.
1,106 studies on the registry are indexed under Dyslipidemias; 166 are open to participants now.
This study's planned enrollment of 190 is above the median of 100 across 865 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →Universiti Teknologi Mara is the lead sponsor of 26 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
I. Male and female aged 18-65 years.
II. Have intermediate (moderate) CVD risk i.e., 10-20% 10-year CVD risk based on Framingham Risk Score AND have LDL-C level of >2.6 mmol/L on 10-20 mg of atorvastatin, 5-10 mg of rosuvastatin or 20-40 mg of simvastatin (NICE, 2023).
III. BMI of 18.5 - 40.0kg/m2.
IV. TG of >1.7 mmol/L.
V. Willing to refrain from consumption of other probiotic products, oat products, barley products and psyllium husk products during the intervention period.
Exclusion Criteria:
I. Use of probiotics or prebiotics within 6 weeks before inclusion. II. Systemic antibiotics within 6 weeks before inclusion. III. Daily alcohol consumption >30 mL. IV. Smoker. V. Diagnosed with immunodeficiency. VI. Diagnosed with type I and II diabetes mellitus. VII. Diagnosed with chronic kidney disease (Stage 3, 4, 5; Estimated Glomerular Filtration Rate of 60 ml/min/1.73 m² that has been present for more than three months) (Whelton et al., 2018) VIII. Diagnosed with cancer or any life-threatening illnesses. IX. Diagnosed with decompensated chronic liver disease (e.g., ascites, jaundice, hepatic encephalopathy, or variceal bleeding) (EASL 2018), acute liver failure, acute hepatitis requiring hospitalisation.
X. Diagnosed with clinically significant gastrointestinal disease that may affect nutrient absorption, gut microbiota, or study participation (e.g., inflammatory bowel disease, celiac disease, chronic pancreatitis, short bowel syndrome, gastrointestinal obstruction, or active gastrointestinal infection) XI. Diagnosed with any acute medical condition requiring hospitalisation XII. Diagnosed with organic heart diseases, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy.
XIII. Breast-feeding or pregnant or plan to become pregnant in the next 6-12 months.
XIV. Participation in another clinical trial within the last 6 months. XV. Cognitive impairment and psychological disorders causing incapacity to give informed consent.
XVI. Vulnerable group [e.g. children (\<18 years old), individuals with physical and cognitive disabilities] XVII. Current use of lipid-lowering therapy other than atorvastatin 10-20 mg or simvastatin 20-40 mg or rosuvastatin 5-10 mg, including other statins (pravastatin, lovastatin, fluvastatin, or pitavastatin), ezetimibe, PCSK9 inhibitors, fibrates, omega-3 fatty acid preparations, nicotinic acid (niacin), or any other lipid-lowering medication or supplement.
XVIII. Known hypersensitivity or allergy to probiotics, β-glucan, oats or any component of the investigational or placebo products.
Participants receive a synbiotic combination of Lactobacillus plantarum LAB12 and SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy.
Dietary Supplement: Synbiotic (LAB12 and SWEOAT® Bran)
Participants receive an inactive oat-based placebo that does not contain Lactobacillus plantarum LAB12 or SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy.
Other: Oat-based Placebo
A synbiotic formulation containing 1.7 g of oat-derived β-glucan and 0.5 g of Lactobacillus plantarum LAB12 (1 × 10⁹ CFU/g) per sachet. Administered orally as two sachets daily for 12 weeks.
An inactive, β-glucan-free oat-based powder matched in appearance and packaging to the active synbiotic. Administered orally as two sachets daily for 12 weeks.
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Evaluated as the absolute change in LDL-C concentrations from baseline.
Time frame: Baseline and Week 12
Change from Baseline in Gut Microbiota Profile
Analyzed via 16S rRNA sequencing to assess changes in microbial diversity and relative abundance of taxa
Time frame: Baseline and Week 12
Change from Baseline in Total Cholesterol (TC)
Evaluated as the absolute change in serum Total Cholesterol
Time frame: Baseline and Week 12
Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Evaluated as the absolute change in serum HDL-C
Time frame: Baseline and Week 12
Change from Baseline in Triglycerides (TG)
Evaluated as the absolute change in serum Triglycerides
Time frame: Baseline and Week 12
Change from Baseline in Apolipoprotein B (ApoB)
Evaluated as the absolute change in serum ApoB levels
Time frame: Baseline and Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)
Evaluated as the absolute change in HbA1c percentage
Time frame: Baseline and Week 12
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Evaluated as the absolute change in plasma hsCRP levels
Time frame: Baseline and Week 12
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α)
Evaluated as the absolute change in plasma TNF-α levels
Time frame: Baseline and Week 12
Change from Baseline in Interleukin-6 (IL-6)
Evaluated as the absolute change in plasma IL-6 levels
Time frame: Baseline and Week 12
Change from Baseline in Alanine Transaminase (ALT)
Evaluated as the absolute change in serum ALT levels
Time frame: Baseline and Week 12
Change from Baseline in Alkaline Phosphatase (ALP)
Evaluated as the absolute change in serum ALP levels
Time frame: Baseline and Week 12
Change from Baseline in Body Weight
Evaluated as the absolute change in body weight in kilograms
Time frame: Baseline and Week 12
Change from Baseline in Body Mass Index (BMI)
Evaluated as the absolute change in BMI (calculated as weight in kilograms divided by height in meters squared)
Time frame: Baseline and Week 12
Change from Baseline in Systolic Blood Pressure (SBP)
Evaluated as the absolute change in resting systolic blood pressure
Time frame: Baseline and Week 12
Change from Baseline in Diastolic Blood Pressure (DBP)
Evaluated as the absolute change in resting diastolic blood pressure
Time frame: Baseline and Week 12
Change from Baseline in Waist Circumference (WC)
Evaluated as the absolute change in waist circumference
Time frame: Baseline and Week 12
Change from Baseline in Hip Circumference (HC)
Evaluated as the absolute change in hip circumference
Time frame: Baseline and Week 12
Change from Baseline in Thigh Circumference (TC)
Evaluated as the absolute change in thigh circumference
Time frame: Baseline and Week 12
Change from Baseline in Body Fat Percentage
Evaluated as the absolute change in body fat percentage
Time frame: Baseline and Week 12
Change from Baseline in Urine pH
The number of participants exhibiting newly occurring or worsening clinically significant abnormal chemical urinalysis findings (e.g., proteinuria, glycosuria) compared to baseline
Time frame: Baseline and Week 12
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Universiti Teknologi Mara