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OpenTrials
Completed

NCT Number: NCT05005754

Effect of Probiotics on Cardiometabolic Health

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition and Food Hygiene, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotics

Dietary Supplement

During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.

Placebo Control

Dietary Supplement

During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.

Primary outcomes

  1. Flow-mediated slowing (FMS)

    Time frame: from baseline to 12 weeks after intervention

    FMS is a simple test for endothelial functions measured by Vicorder. In patients whose endothelial function or flow-mediated vasodilation are compromised, the FMS is substantially reduced.

Secondary outcomes

  1. gut microbiota

    Time frame: from baseline to 12 weeks after intervention

    Alterations of the composition of gut microbiota evaluated by metagenomics

  2. microbial metabolites

    Time frame: from baseline to 12 weeks after intervention

    alterations of microbial metabolites evaluated by High performance liquid chromatography-mass spectrometry

  3. Metabolic Syndrome Severity Z Score (MetZ score)

    Time frame: from baseline to 12 weeks after intervention

    MetZ score is an weighted score of the five traditional components of Metabolic syndrome (waist, triglyceride, HDL cholesterol, SBP and fasting glucose). It's used to evaluate the severity of metabolic disorder, and a higher score indicates a more severe status.

  4. Lipid profiles

    Time frame: from baseline to 12 weeks after intervention

    alterations of blood lipids including total cholesterol, triglyceride, LDL cholesterol and HDL cholesterol determined by automatic biochemical analyser

  5. Blood pressure

    Time frame: from baseline to 12 weeks after intervention

    alterations of blood pressure

  6. Insulin sensitivity

    Time frame: from baseline to 12 weeks after intervention

    alterations of HOMA-IR index

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

An Interventional Study for the Beneficial Effects of Probiotics on Cardio-metabolic Health in Chinese Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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