DyslipidemiaPhase 2NCT07915687
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
A Phase 2 study testing Synbiotic (LAB12 and SWEOAT® Bran) in people with Dyslipidemia, run by Universiti Teknologi Mara at 1 site in Malaysia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Synbiotic (LAB12 and SWEOAT® Bran)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Dec 2026to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female aged 18-65 years.
- 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).
- BMI of 18.5 - 40.0kg/m2.
- TG of >1.7 mmol/L.
- Willing to refrain from consumption of other probiotic products, oat products, barley products and psyllium husk products during the intervention period.
Who cannot join
- Use of probiotics or prebiotics within 6 weeks before inclusion.
- Systemic antibiotics within 6 weeks before inclusion.
- Daily alcohol consumption >30 mL.
- Smoker.
- Diagnosed with immunodeficiency.
- Diagnosed with type I and II diabetes mellitus.
Show all 18Show fewer
- 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)
- Diagnosed with cancer or any life-threatening illnesses.
- Diagnosed with decompensated chronic liver disease (e.g., ascites, jaundice, hepatic encephalopathy, or variceal bleeding) (EASL 2018), acute liver failure, acute hepatitis requiring hospitalisation.
- 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)
- Diagnosed with any acute medical condition requiring hospitalisation
- Diagnosed with organic heart diseases, including but not limited to congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy.
- Breast-feeding or pregnant or plan to become pregnant in the next 6-12 months.
- Participation in another clinical trial within the last 6 months.
- Cognitive impairment and psychological disorders causing incapacity to give informed consent.
- Vulnerable group [e.g. children (<18 years old), individuals with physical and cognitive disabilities]
- 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.
- Known hypersensitivity or allergy to probiotics, β-glucan, oats or any component of the investigational or placebo products.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nur Atiqah Kamal Rodin contact
Malaysia1 site
Primary Care Clinic, UiTM Sungai Buloh Campus
Sungai Buloh, Selangor, 4700
About this study
Official title: 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.
- Conditions
- Dyslipidemia
- Being tested
- Synbiotic (LAB12 and SWEOAT® Bran), Oat-based Placebo
- Keywords
- synbiotics, statin, dyslipidemia, gut microbiota
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synbiotic (LAB12 and SWEOAT® Bran)Dietary supplement
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.
Oat-based PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| LAB12 Synbiotic Group | Experimental | Participants receive a synbiotic combination of Lactobacillus plantarum LAB12 and SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy. Receives: Dietary Supplement: Synbiotic (LAB12 and SWEOAT® Bran) |
| Placebo group | Placebo comparator | 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. Receives: Other: Oat-based Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Evaluated as the absolute change in LDL-C concentrations from baseline.
Measured: Baseline and Week 12
Secondary outcomes (20)
Change from Baseline in Gut Microbiota Profile
Analyzed via 16S rRNA sequencing to assess changes in microbial diversity and relative abundance of taxa
Measured: Baseline and Week 12
Change from Baseline in Total Cholesterol (TC)
Evaluated as the absolute change in serum Total Cholesterol
Measured: Baseline and Week 12
Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Evaluated as the absolute change in serum HDL-C
Measured: Baseline and Week 12
Change from Baseline in Triglycerides (TG)
Evaluated as the absolute change in serum Triglycerides
Measured: Baseline and Week 12
Change from Baseline in Apolipoprotein B (ApoB)
Evaluated as the absolute change in serum ApoB levels
Measured: Baseline and Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)
Evaluated as the absolute change in HbA1c percentage
Measured: Baseline and Week 12
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Evaluated as the absolute change in plasma hsCRP levels
Measured: Baseline and Week 12
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α)
Evaluated as the absolute change in plasma TNF-α levels
Measured: Baseline and Week 12
Change from Baseline in Interleukin-6 (IL-6)
Evaluated as the absolute change in plasma IL-6 levels
Measured: Baseline and Week 12
Change from Baseline in Alanine Transaminase (ALT)
Evaluated as the absolute change in serum ALT levels
Measured: Baseline and Week 12
Change from Baseline in Alkaline Phosphatase (ALP)
Evaluated as the absolute change in serum ALP levels
Measured: Baseline and Week 12
Change from Baseline in Body Weight
Evaluated as the absolute change in body weight in kilograms
Measured: 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)
Measured: Baseline and Week 12
Change from Baseline in Systolic Blood Pressure (SBP)
Evaluated as the absolute change in resting systolic blood pressure
Measured: Baseline and Week 12
Change from Baseline in Diastolic Blood Pressure (DBP)
Evaluated as the absolute change in resting diastolic blood pressure
Measured: Baseline and Week 12
Change from Baseline in Waist Circumference (WC)
Evaluated as the absolute change in waist circumference
Measured: Baseline and Week 12
Change from Baseline in Hip Circumference (HC)
Evaluated as the absolute change in hip circumference
Measured: Baseline and Week 12
Change from Baseline in Thigh Circumference (TC)
Evaluated as the absolute change in thigh circumference
Measured: Baseline and Week 12
Change from Baseline in Body Fat Percentage
Evaluated as the absolute change in body fat percentage
Measured: 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
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start2 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Teknologi Mara
- Sponsor type
- University, hospital or other
- Collaborators
- Dong Foong Manufacturing Sdn. Bhd.
- Responsible party
- Principal investigator, Kalavathy Ramasamy, Universiti Teknologi Mara
- Investigators
- Kalavathy Ramasamy, Professor Dr, Study director, Universiti Teknologi MaraLim Siong Meng, Professor Dr, Study chair, Universiti Teknologi Mara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915687
- Sponsor's protocol ID
- PG/FB/38
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health: A Randomised Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07915687
- Acronym / sponsor ID
- PG/FB/38
- Conditions
- Dyslipidemia
- Keywords
- synbiotics, statin, dyslipidemia, gut microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Universiti Teknologi MaraUniversity, hospital or other
- Collaborators
- Dong Foong Manufacturing Sdn. Bhd.
- Study start
- 2 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LAB12 Synbiotic Group | Experimental | Dietary Supplement: Synbiotic (LAB12 and SWEOAT® Bran)Participants receive a synbiotic combination of Lactobacillus plantarum LAB12 and SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy. |
| Placebo group | Placebo comparator | Other: Oat-based PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female aged 18-65 years.
- 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).
- BMI of 18.5 - 40.0kg/m2.
- TG of >1.7 mmol/L.
- Willing to refrain from consumption of other probiotic products, oat products, barley products and psyllium husk products during the intervention period.
Key exclusion criteria (18 listed)
- Use of probiotics or prebiotics within 6 weeks before inclusion.
- Systemic antibiotics within 6 weeks before inclusion.
- Daily alcohol consumption >30 mL.
- Smoker.
- Diagnosed with immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | LAB12 Synbiotic Group |
| Oat-based PlaceboAn 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. | Other | Placebo group |
Primary outcome
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and Week 12
Evaluated as the absolute change in LDL-C concentrations from baseline.
20 secondary outcomes
Change from Baseline in Gut Microbiota Profile
Time frame: Baseline and Week 12
Change from Baseline in Total Cholesterol (TC)
Time frame: Baseline and Week 12
Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Time frame: Baseline and Week 12
Change from Baseline in Triglycerides (TG)
Time frame: Baseline and Week 12
Change from Baseline in Apolipoprotein B (ApoB)
Time frame: Baseline and Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline and Week 12
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline and Week 12
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α)
Time frame: Baseline and Week 12
Change from Baseline in Interleukin-6 (IL-6)
Time frame: Baseline and Week 12
Change from Baseline in Alanine Transaminase (ALT)
Time frame: Baseline and Week 12
Change from Baseline in Alkaline Phosphatase (ALP)
Time frame: Baseline and Week 12
Change from Baseline in Body Weight
Time frame: Baseline and Week 12
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline and Week 12
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline and Week 12
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline and Week 12
Change from Baseline in Waist Circumference (WC)
Time frame: Baseline and Week 12
Change from Baseline in Hip Circumference (HC)
Time frame: Baseline and Week 12
Change from Baseline in Thigh Circumference (TC)
Time frame: Baseline and Week 12
Change from Baseline in Body Fat Percentage
Time frame: Baseline and Week 12
Change from Baseline in Urine pH
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nur Atiqah Kamal Rodin contact
Kalavathy Ramasamy, Professor Dr study director
Universiti Teknologi Mara
Lim Siong Meng, Professor Dr study chair
Universiti Teknologi Mara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Synbiotic (LAB12 and SWEOAT® Bran) in people with Dyslipidemia, run by Universiti Teknologi Mara at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Amirul Izzan Amran, Dr (+60199322400, 2024860784@student.uitm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.