Effect of Probiotics on Cardiometabolic Health

NCT05005754 | Completed

• 1 other identifier: Pro-2021
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiometabolic Risk Factors

Outcome Measures

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.

  from baseline to 12 weeks after intervention

Secondary Outcomes (6)

• gut microbiota

  from baseline to 12 weeks after intervention

• microbial metabolites

  from baseline to 12 weeks after intervention

• Metabolic Syndrome Severity Z Score (MetZ score)

  from baseline to 12 weeks after intervention

• Lipid profiles

  from baseline to 12 weeks after intervention

• Blood pressure

  from baseline to 12 weeks after intervention

Study Arms (2)

Probiotics

EXPERIMENTAL

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

Dietary Supplement: Probiotics

Placebo Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo control

Interventions

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.

Probiotics

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.

Placebo Control

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Department of Nutrition and Food Hygiene

Guangzhou, Guangdong, 510080, China

Location

Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• 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.

  PMID: 37506599 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: August 16, 2021
• Study Start: September 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)