The effects of Lactobacillus plantarum INDUCIA® probiotic in healthy volunteers with elevated cholesterol

Not Applicable

Completed

• Conditions: Elevated cholesterol levels; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11616457
• Lead Sponsor: BioCC LCC (formerly Bio-Competence Centre of Healthy Dairy Products (Estonia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-30
• Study Start: 2023-01-13
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

1. Written informed consent
2. Aged between 30 and 65 years old
3. Willingness to maintain a stable diet and physical activity level
4. Willingness to cease using probiotic products and supplements (except vitamin D) during the study period
5. Normal or not clinically relevant deviations in safety laboratory values
6. One of the following outcomes at the screening visit: LDL-cholesterol value >3.4 mmol/L; LDL-cholesterol/HDL-cholesterol >3.5 mmol/L or total cholesterol/HDL between 3.5 and 4.5 mmol/

Exclusion Criteria

1. Using blood pressure and/or cholesterol lowering drugs/supplements within the last 3 months prior to start of the study (i.e. baseline visit)
2. Diabetes
3. Acute or chronic inflammatory disease
4. Endocrinological disease
5. (Food) allergy
6. Using antibiotic within the last 4 weeks prior to start of the study (i.e. baseline visit)
7. Using NSAIDs regularly
8. Pregnancy and breastfeeding
9. Donor within the last 3 months prior to start of the study (i.e. baseline visit)
10. Smoking
11. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study
12. Intolerance to the investigational product/its ingredients
13. Acute infection within the last 2 weeks prior to baseline
14. Eating disorder
15. Extensive exercise (daily training of professional athletes)
16. Drug or alcohol abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. LDL-cholesterol level in blood serum at baseline, and weeks 8, 12 and 14<br>2. Total-cholesterol level in blood serum at baseline, and weeks 8, 12 and 14<br>3. Oxidative stress indices measured from blood and urine samples using different ELISA-based assays at baseline, and weeks 8 and 12<br>4. Gut microflora indices (lactoflora, anaerobes etc) measured from stool samples using molecular approaches and specific primers at baseline, and weeks 8, 12 and 14

Secondary Outcome Measures

Name	Time	Method
1. Metabolic syndrome indices measured from blood samples using different ELISA-based assays at baseline, and weeks 8 and 12<br>2. Short-chain fatty acids (SCFA) measured from stool and urine samples using High-Pressure Liquid Chromatography (HPLC) at baseline, and weeks 8, 12 and 14<br>3. Bile acids concentration measured from stool and urine samples High-Pressure Liquid Chromatography (HPLC) at baseline, and weeks 8, 12 and 14