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Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health

30. oktober 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

190

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LAB12 Synbiotic Group

Participants receive a synbiotic combination of Lactobacillus plantarum LAB12 and SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy.
Kosttilskud: 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 komparator: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Tidsramme: Baseline and Week 12

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Gut Microbiota Profile
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline and Week 12

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

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

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

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

Evaluated as the absolute change in serum ALP levels
Baseline and Week 12
Change from Baseline in Body Weight
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline and Week 12

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

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

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

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Universiti Teknologi Mara

Samarbejdspartnere

Dong Foong Manufacturing Sdn. Bhd.

Efterforskere

  • Studieleder: Kalavathy Ramasamy, Professor Dr, Universiti Teknologi Mara
  • Studiestol: Lim Siong Meng, Professor Dr, Universiti Teknologi Mara

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. december 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

21. oktober 2026

Først indsendt, der opfyldte QC-kriterier

30. oktober 2026

Først opslået (Faktiske)

4. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PG/FB/38

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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