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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Mohammad Amirul Izzan Amran, Dr
- Telefonní číslo: +60199322400
- E-mail: 2024860784@student.uitm.edu.my
Studijní záloha kontaktů
- Jméno: Nur Atiqah Kamal Rodin
- E-mail: nuratiqahkr@uitm.edu.my
Studijní místa
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Selangor
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Sungai Buloh, Selangor, Malajsie, 4700
- Primary Care Clinic, UiTM Sungai Buloh Campus
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: LAB12 Synbiotic Group
Participants receive a synbiotic combination of Lactobacillus plantarum LAB12 and SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy. |
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. |
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Komparátor placeba: 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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in LDL-C concentrations from baseline. |
Baseline and Week 12
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from Baseline in Gut Microbiota Profile
Časové okno: Baseline and Week 12
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Analyzed via 16S rRNA sequencing to assess changes in microbial diversity and relative abundance of taxa |
Baseline and Week 12
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Change from Baseline in Total Cholesterol (TC)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in serum Total Cholesterol |
Baseline and Week 12
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Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in serum HDL-C |
Baseline and Week 12
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Change from Baseline in Triglycerides (TG)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in serum Triglycerides |
Baseline and Week 12
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Change from Baseline in Apolipoprotein B (ApoB)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in serum ApoB levels |
Baseline and Week 12
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Change from Baseline in Hemoglobin A1c (HbA1c)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in HbA1c percentage |
Baseline and Week 12
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Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in plasma hsCRP levels |
Baseline and Week 12
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Change from Baseline in Tumor Necrosis Factor-alpha (TNF-α)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in plasma TNF-α levels |
Baseline and Week 12
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Change from Baseline in Interleukin-6 (IL-6)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in plasma IL-6 levels |
Baseline and Week 12
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Change from Baseline in Alanine Transaminase (ALT)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in serum ALT levels |
Baseline and Week 12
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Change from Baseline in Alkaline Phosphatase (ALP)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in serum ALP levels |
Baseline and Week 12
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Change from Baseline in Body Weight
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in body weight in kilograms |
Baseline and Week 12
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Change from Baseline in Body Mass Index (BMI)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in BMI (calculated as weight in kilograms divided by height in meters squared) |
Baseline and Week 12
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Change from Baseline in Systolic Blood Pressure (SBP)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in resting systolic blood pressure |
Baseline and Week 12
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Change from Baseline in Diastolic Blood Pressure (DBP)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in resting diastolic blood pressure |
Baseline and Week 12
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Change from Baseline in Waist Circumference (WC)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in waist circumference |
Baseline and Week 12
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Change from Baseline in Hip Circumference (HC)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in hip circumference |
Baseline and Week 12
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Change from Baseline in Thigh Circumference (TC)
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in thigh circumference |
Baseline and Week 12
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Change from Baseline in Body Fat Percentage
Časové okno: Baseline and Week 12
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Evaluated as the absolute change in body fat percentage |
Baseline and Week 12
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Change from Baseline in Urine pH
Časové okno: Baseline and Week 12
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Kalavathy Ramasamy, Professor Dr, Universiti Teknologi Mara
- Studijní židle: Lim Siong Meng, Professor Dr, Universiti Teknologi Mara
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PG/FB/38
Informace o lécích a zařízeních, studijní dokumenty
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