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Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health

2026년 10월 30일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

190

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: LAB12 Synbiotic Group

Participants receive a synbiotic combination of Lactobacillus plantarum LAB12 and SWEOAT® Bran, taken in addition to their standard background dyslipidaemia therapy.
건강 보조 식품: 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.
위약 비교기: 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.
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
기간: Baseline and Week 12

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

2차 결과 측정

결과 측정
측정값 설명
기간
Change from Baseline in Gut Microbiota Profile
기간: 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)
기간: 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)
기간: Baseline and Week 12

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

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

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

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

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

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

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

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

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Universiti Teknologi Mara

협력자

Dong Foong Manufacturing Sdn. Bhd.

수사관

  • 연구 책임자: Kalavathy Ramasamy, Professor Dr, Universiti Teknologi Mara
  • 연구 의자: Lim Siong Meng, Professor Dr, Universiti Teknologi Mara

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 12월 2일

기본 완료 (추정된)

2027년 6월 1일

연구 완료 (추정된)

2028년 6월 1일

연구 등록 날짜

최초 제출

2026년 10월 21일

QC 기준을 충족하는 최초 제출

2026년 10월 30일

처음 게시됨 (실제)

2026년 11월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 30일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PG/FB/38

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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