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Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health

30 ottobre 2026 aggiornato da: Kalavathy Ramasamy, Universiti Teknologi Mara

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

190

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: LAB12 Synbiotic Group

Participants receive a synbiotic combination of Lactobacillus plantarum LAB12 and SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy.
Integratore alimentare: 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.
Comparatore placebo: 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.
Altro: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in LDL-C concentrations from baseline.
Baseline and Week 12

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from Baseline in Gut Microbiota Profile
Lasso di tempo: Baseline and Week 12

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)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in serum Total Cholesterol
Baseline and Week 12
Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in serum HDL-C
Baseline and Week 12
Change from Baseline in Triglycerides (TG)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in serum Triglycerides
Baseline and Week 12
Change from Baseline in Apolipoprotein B (ApoB)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in serum ApoB levels
Baseline and Week 12
Change from Baseline in Hemoglobin A1c (HbA1c)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in HbA1c percentage
Baseline and Week 12
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in plasma hsCRP levels
Baseline and Week 12
Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in plasma TNF-α levels
Baseline and Week 12
Change from Baseline in Interleukin-6 (IL-6)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in plasma IL-6 levels
Baseline and Week 12
Change from Baseline in Alanine Transaminase (ALT)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in serum ALT levels
Baseline and Week 12
Change from Baseline in Alkaline Phosphatase (ALP)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in serum ALP levels
Baseline and Week 12
Change from Baseline in Body Weight
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in body weight in kilograms
Baseline and Week 12
Change from Baseline in Body Mass Index (BMI)
Lasso di tempo: Baseline and Week 12

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)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in resting systolic blood pressure
Baseline and Week 12
Change from Baseline in Diastolic Blood Pressure (DBP)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in resting diastolic blood pressure
Baseline and Week 12
Change from Baseline in Waist Circumference (WC)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in waist circumference
Baseline and Week 12
Change from Baseline in Hip Circumference (HC)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in hip circumference
Baseline and Week 12
Change from Baseline in Thigh Circumference (TC)
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in thigh circumference
Baseline and Week 12
Change from Baseline in Body Fat Percentage
Lasso di tempo: Baseline and Week 12

Evaluated as the absolute change in body fat percentage
Baseline and Week 12
Change from Baseline in Urine pH
Lasso di tempo: Baseline and Week 12

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universiti Teknologi Mara

Collaboratori

Dong Foong Manufacturing Sdn. Bhd.

Investigatori

  • Direttore dello studio: Kalavathy Ramasamy, Professor Dr, Universiti Teknologi Mara
  • Cattedra di studio: Lim Siong Meng, Professor Dr, Universiti Teknologi Mara

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

2 dicembre 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 giugno 2028

Date di iscrizione allo studio

Primo inviato

21 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 ottobre 2026

Primo Inserito (Effettivo)

4 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PG/FB/38

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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