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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Mohammad Amirul Izzan Amran, Dr
- Numer telefonu: +60199322400
- E-mail: 2024860784@student.uitm.edu.my
Kopia zapasowa kontaktu do badania
- Nazwa: Nur Atiqah Kamal Rodin
- E-mail: nuratiqahkr@uitm.edu.my
Lokalizacje studiów
-
-
Selangor
-
Sungai Buloh, Selangor, Malezja, 4700
- Primary Care Clinic, UiTM Sungai Buloh Campus
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Komparator 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. |
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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in LDL-C concentrations from baseline. |
Baseline and Week 12
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change from Baseline in Gut Microbiota Profile
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in serum HDL-C |
Baseline and Week 12
|
|
Change from Baseline in Triglycerides (TG)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in serum Triglycerides |
Baseline and Week 12
|
|
Change from Baseline in Apolipoprotein B (ApoB)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in serum ApoB levels |
Baseline and Week 12
|
|
Change from Baseline in Hemoglobin A1c (HbA1c)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in serum ALT levels |
Baseline and Week 12
|
|
Change from Baseline in Alkaline Phosphatase (ALP)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in serum ALP levels |
Baseline and Week 12
|
|
Change from Baseline in Body Weight
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in waist circumference |
Baseline and Week 12
|
|
Change from Baseline in Hip Circumference (HC)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in hip circumference |
Baseline and Week 12
|
|
Change from Baseline in Thigh Circumference (TC)
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in thigh circumference |
Baseline and Week 12
|
|
Change from Baseline in Body Fat Percentage
Ramy czasowe: Baseline and Week 12
|
Evaluated as the absolute change in body fat percentage |
Baseline and Week 12
|
|
Change from Baseline in Urine pH
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Dyrektor Studium: Kalavathy Ramasamy, Professor Dr, Universiti Teknologi Mara
- Krzesło do nauki: Lim Siong Meng, Professor Dr, Universiti Teknologi Mara
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PG/FB/38
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .