Clinical trial NCT05005754: Effect of Probiotics on Cardiometabolic Health
Official title: An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk Factors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 130
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms. This trial aims to examine its protective effect in humans.

Detailed description: Atherosclerosis is a major risk factor for cardiovascular diseases. Recently, dysbiosis of gut microbiota has been reported to play an important role in the pathogenesis of atherosclerosis. Animal studies have demonstrated that administration of probiotics help delay the progression of atherosclerosis through several mechanisms such as reduction in endotoxemia, and enhanced production of short-chain fatty acids.

However, whether administration of probiotics also has a protective effect in subjects with metabolic syndrome (MetS), who are at high risk for developing atherosclerosis, remain unknown.

Eligibility criteria: Inclusion Criteria:

* Local residents aged between 30-60 years old;
* Stable weight (\<5% weight change over last 3 months);
* Central obesity defined as waist circumference ≥90 cm in males or ≥80 cm in females, Plus any two of the following four conditions i) Elevated triglycerides: serum triglycerides ≥150 mg/dL (1.7 mmol/L); ii) Reduced HDL cholesterol: serum HDL-c \<40 mg/dL (1.03 mmol/L) in males or \<50 mg/dL (1.29 mmol/L) in females; iii) Elevated blood pressure: systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg; iv) Elevated fasting plasma glucose: fasting plasma glucose ≥100 mg/dL (5.6 mmol/L)
* Absence of any systemic, cardiovascular diseases, as well as infections within the previous month;
* Absence of any diet or medication that might interfere with metabolic homoeostasis and gut microbiota, especially antibiotics and probiotics 4 weeks before recruitment.

Exclusion Criteria:

* Acute illness or current evidence of acute or chronic inflammatory of infective diseases;
* Participation in regular diet program more than 2 times per week in the latest 3 months prior to recruitment;
* Mental illness rendering them unable to understand the nature, scope, and possible consequences of the study.

Primary outcomes:
measure: Flow-mediated slowing (FMS)
timeFrame: from baseline to 12 weeks after intervention
Secondary outcomes:
measure: gut microbiota
timeFrame: from baseline to 12 weeks after intervention
measure: microbial metabolites
timeFrame: from baseline to 12 weeks after intervention
measure: Metabolic Syndrome Severity Z Score (MetZ score)
timeFrame: from baseline to 12 weeks after intervention
measure: Lipid profiles
timeFrame: from baseline to 12 weeks after intervention
measure: Blood pressure
timeFrame: from baseline to 12 weeks after intervention
measure: Insulin sensitivity
timeFrame: from baseline to 12 weeks after intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Nutrition and Food Hygiene
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen University
state: Guangdong
Study officials:
References: