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CompletedNCT05005754Updated May 5, 2022

Effect of Probiotics on Cardiometabolic Health

An interventional study of Probiotics and Placebo control in Cardiometabolic Risk Factors, sponsored by Sun Yat-sen University. Completed at 2 sites in China. Open to participants aged 30 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
30 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiometabolic Risk Factors
03

In context

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,681 studies on the registry; 610 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Probiotics

    Subjects are instructed to take one capsule of probiotics daily for a total of 3 months

    Dietary Supplement: Probiotics

  • Placebo comparator
    Placebo Control

    Subjects are instructed to take one capsule of placebo daily for a total of 3 months

    Dietary Supplement: Placebo control

Interventions

  • Dietary supplementProbiotics

    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.

  • Dietary supplementPlacebo control

    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.

06

What researchers measure

Primary outcomes

  1. Flow-mediated slowing (FMS)

    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.

    Time frame: from baseline to 12 weeks after intervention

Secondary outcomes

  1. gut microbiota

    Alterations of the composition of gut microbiota evaluated by metagenomics

    Time frame: from baseline to 12 weeks after intervention

  2. microbial metabolites

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

    Time frame: from baseline to 12 weeks after intervention

  3. Metabolic Syndrome Severity Z Score (MetZ score)

    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.

    Time frame: from baseline to 12 weeks after intervention

  4. Lipid profiles

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

    Time frame: from baseline to 12 weeks after intervention

  5. Blood pressure

    alterations of blood pressure

    Time frame: from baseline to 12 weeks after intervention

  6. Insulin sensitivity

    alterations of HOMA-IR index

    Time frame: from baseline to 12 weeks after intervention

07

Study locations

2 sites
  • Department of Nutrition and Food Hygiene
    Guangzhou, Guangdong 510080, China
  • Sun Yat-Sen University
    Guangzhou, Guangdong 510080, China
08

References and documents

Publications

  • Yang J, Huang J, Huang Z, Xu Y, Li W, Zhu S, Zhao Y, Ye B, Liu L, Zhu J, Xia M, Liu Y. Cardiometabolic benefits of Lacticaseibacillus paracasei 8700:2: A randomized double-blind placebo-controlled trial. Clin Nutr. 2023 Sep;42(9):1637-1646. doi: 10.1016/j.clnu.2023.07.017. Epub 2023 Jul 21. PubMed 37506599 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in Feb 2022, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 8, 2021
First posted
Aug 16, 2021
StartActual
Sep 1, 2021
Primary completionActual
Feb 28, 2022
CompletionActual
Feb 28, 2022
Last update
May 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05005754
Lead sponsor
Sun Yat-sen University
Responsible party
Min Xia (Professor, Sun Yat-sen University) — Principal investigator
First posted
Aug 16, 2021
Start date
Sep 1, 2021
Primary completion
Feb 28, 2022
Completion
Feb 28, 2022
Last update
May 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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