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Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health

30. Oktober 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

190

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Nahrungsergänzungsmittel: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Zeitfenster: Baseline and Week 12

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Gut Microbiota Profile
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Baseline and Week 12

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

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

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

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

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

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

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

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

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Universiti Teknologi Mara

Mitarbeiter

Dong Foong Manufacturing Sdn. Bhd.

Ermittler

  • Studienleiter: Kalavathy Ramasamy, Professor Dr, Universiti Teknologi Mara
  • Studienstuhl: Lim Siong Meng, Professor Dr, Universiti Teknologi Mara

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

2. Dezember 2026

Primärer Abschluss (Geschätzt)

1. Juni 2027

Studienabschluss (Geschätzt)

1. Juni 2028

Studienanmeldedaten

Zuerst eingereicht

21. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. Oktober 2026

Zuerst gepostet (Tatsächlich)

4. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PG/FB/38

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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