Effect of Probiotics on Lipid Management

NCT03952169 | Unknown DMC

• 1 other identifier: ProHealth-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Dysbiosis of gut microbiota has been reported to be involved in the development of hypercholesterolemia in both humans and animal models. Probiotics have been reported to have ameliorative effects in murine models. However, whether probiotics could help alleviate dyslipidemia in adults remain obscure.

Conditions

Primary Hypercholesterolemia

Keywords

Primary Hypercholesterolemia; Probiotics; Cardiovascular risk

Outcome Measures

Primary Outcomes (5)

• Total cholesterol

  changes of total cholesterol levels in plasma by automatic biochemical analyzer

  baseline, 4 weeks, 8 weeks and 12 weeks

• LDL-cholesterol

  changes of LDL-cholesterol levels in plasma by automatic biochemical analyzer

  baseline, 4 weeks, 8 weeks and 12 weeks

• Triglyceride

  changes of triglyceride levels in plasma by automatic biochemical analyzer

  baseline, 4 weeks, 8 weeks and 12 weeks

• non HDL-cholesterol

  changes of non HDL-cholesterol levels in plasma

  baseline, 4 weeks, 8 weeks and 12 weeks

• gut microbiota

  changes of gut microbiota by metagenomics

  baseline, 4 week, 8 weeks and 12 weeks

Secondary Outcomes (4)

• blood pressure

  baseline, 4 week, 8 week and 12 weeks

• pulse wave velocity

  baseline and after 12-week intervention

• ankle Brachial Index

  baseline and after 12-week intervention

• microbial metabolite

  baseline and after 12-week intervention

Study Arms (2)

Probiotics group

EXPERIMENTAL

Participants will be given capsules containing Lactobacillus paracasei once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Dietary Supplement: Lactobacillus paracasei dietary supplement

Placebo group

PLACEBO COMPARATOR

Participants will be given capsules containing microcrystalline cellulose once daily for 12 weeks followed by comprehensive physical and clinical examinations.

Other: Placebo controls

Interventions

Lactobacillus paracasei dietary supplement DIETARY_SUPPLEMENT

a commercial probiotic dietary supplement

Probiotics group

Placebo controls OTHER

placebo with a similar appearance to probiotics supplement

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible subjects include men and women 18 to 75 years of age with primary hypercholesterolemia who has a total cholesterol level of 5.18 mmol/L or higher and/ or an LDL cholesterol level of 2.59 mmol/L or higher;
• Absence of any diet, dietary supplement and medication that might interfere with lipid homoeostasis and gut microbiota, especially antibiotics and probiotics.

You may not qualify if:

• Triglyceride levels higher than 3.95 mmol/L, or any other systemic, metabolic and cardiovascular or cerebrovascular diseases;
• Type 1 diabetes, type 2 diabetes treated with insulin or other medications;
• Acute illness or current evidence of acute or chronic inflammatory or infective diseases;
• Participation in any diet or lifestyle 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 (1)

Department of Nutrition and Food Hygiene

Guangzhou, Guangdong, 510080, China

Location

Study Officials

• Min Xia, PhD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators and care providers at the scene are all blinded to the allocation of treatment group. Data collected will be analyzed by another investigator who is blinded to the study design.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: placebo-controlled, randomized clinical trial

Study Record Dates

• First Submitted: May 12, 2019
• First Posted: May 16, 2019
• Study Start: May 12, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)