Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health

Evaluation of Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health: A Randomised Double-blind, Placebo-controlled Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dyslipidemia
• Intervention / Treatment: Dietary supplement: Synbiotic (LAB12 and SWEOAT® Bran); Other: Oat-based Placebo

• Study Type: Interventional
• Enrollment (Estimated): 190
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mohammad Amirul Izzan Amran, Dr; Phone Number: +60199322400; Email: 2024860784@student.uitm.edu.my
• Study Contact Backup: Name: Nur Atiqah Kamal Rodin; Email: nuratiqahkr@uitm.edu.my

Study Locations

• Malaysia
  • Selangor
    • Sungai Buloh, Selangor, Malaysia, 4700
      • Primary Care Clinic, UiTM Sungai Buloh Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAB12 Synbiotic Group; 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); 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.
Placebo Comparator: Placebo group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)	Evaluated as the absolute change in LDL-C concentrations from baseline.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Gut Microbiota Profile	Analyzed via 16S rRNA sequencing to assess changes in microbial diversity and relative abundance of taxa	Baseline and Week 12
Change from Baseline in Total Cholesterol (TC)	Evaluated as the absolute change in serum Total Cholesterol	Baseline and Week 12
Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)	Evaluated as the absolute change in serum HDL-C	Baseline and Week 12
Change from Baseline in Triglycerides (TG)	Evaluated as the absolute change in serum Triglycerides	Baseline and Week 12
Change from Baseline in Apolipoprotein B (ApoB)	Evaluated as the absolute change in serum ApoB levels	Baseline and Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)	Evaluated as the absolute change in HbA1c percentage	Baseline and Week 12
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)	Evaluated as the absolute change in plasma hsCRP levels	Baseline and Week 12
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α)	Evaluated as the absolute change in plasma TNF-α levels	Baseline and Week 12
Change from Baseline in Interleukin-6 (IL-6)	Evaluated as the absolute change in plasma IL-6 levels	Baseline and Week 12
Change from Baseline in Alanine Transaminase (ALT)	Evaluated as the absolute change in serum ALT levels	Baseline and Week 12
Change from Baseline in Alkaline Phosphatase (ALP)	Evaluated as the absolute change in serum ALP levels	Baseline and Week 12
Change from Baseline in Body Weight	Evaluated as the absolute change in body weight in kilograms	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)	Baseline and Week 12
Change from Baseline in Systolic Blood Pressure (SBP)	Evaluated as the absolute change in resting systolic blood pressure	Baseline and Week 12
Change from Baseline in Diastolic Blood Pressure (DBP)	Evaluated as the absolute change in resting diastolic blood pressure	Baseline and Week 12
Change from Baseline in Waist Circumference (WC)	Evaluated as the absolute change in waist circumference	Baseline and Week 12
Change from Baseline in Hip Circumference (HC)	Evaluated as the absolute change in hip circumference	Baseline and Week 12
Change from Baseline in Thigh Circumference (TC)	Evaluated as the absolute change in thigh circumference	Baseline and Week 12
Change from Baseline in Body Fat Percentage	Evaluated as the absolute change in body fat percentage	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	Baseline and Week 12

Collaborators and Investigators

• Sponsor: Universiti Teknologi Mara
• Collaborators: Dong Foong Manufacturing Sdn. Bhd.
• Investigators: Study Director: Kalavathy Ramasamy, Professor Dr, Universiti Teknologi Mara; Study Chair: Lim Siong Meng, Professor Dr, Universiti Teknologi Mara

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: October 21, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: gut microbiota; dyslipidemia; statin; synbiotics
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Dyslipidemias; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Prebiotics; Probiotics; Synbiotics
• Other Study ID Numbers: PG/FB/38

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No