Effect of Probiotics on Cardiometabolic Health

NCT ID: NCT05005754

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-02-28

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.

Conditions

Cardiometabolic Risk Factors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotics

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

Group Type: EXPERIMENTAL

Probiotics

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Placebo control

Intervention Type: 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.

Interventions

Probiotics

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Min Xia

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Nutrition and Food Hygiene

Guangzhou, Guangdong, China

Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37506599 (View on PubMed)

Other Identifiers

Pro-2021

Identifier Type: -

Identifier Source: org_study_id