Effect of novel probiotic food supplement on elevated cardiometabolic and inflammatory markers on clinically asymptomatic volunteers.

Not Applicable

Completed

• Conditions: Elevated values of blood lipids, oxidative stress, inflammation and blood glucose related indices.; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN55339917
• Lead Sponsor: GIE Eurasanté (France)

Brief Summary

2016 results in https://pubmed.ncbi.nlm.nih.gov/27793203/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-12
• Study Completion: 2015-03-31
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. A written informed consent
2. Aged between 40 - 70 years
3. No known health problems
4. Total cholesterol higher than 5.3 mmol/L or LDL-chol higher than 3.0mmol/L or triglycerides higher than 1.7 mmol/L or total cholesterol/HDL higher than 4 or LDL/HDL higher than 3 or glycated Hb higher than 5.7% or hsCRP higher than 1,0 mg/L or homocysteine higher than 11 micromol/L
5. No use of any concomitant treatment which could influence the evaluation of the efficacy and the tolerability of the investigational study product, including lipid lowering drugs (e.g. statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid), supplementation with e.g. omega-3 fatty acids, calcium, oat fiber, niacin, green tea extract, plant sterols, vitamins, soy protein, psyllium seed husk or probiotics/prebiotics within the preceding at least 3 weeks
6. Willingness to maintain a stable diet and physical activity level

Exclusion Criteria

1. Pregnancy and breastfeeding
2. History of gastrointestinal disease
3. Food allergy
4. Diabetes
5. Acute infection within the last 3 weeks prior to enrolment
6. Use of any antimicrobial agents within the preceding 2 months
7. Use of any regular concomitant medication including any non-steroidal anti-inflammatory drugs and antioxidant products 3 weeks
8. Intolerance to the investigational product / its ingredients
9. Any kind of concurrent disease which could influence the evaluation of the efficacy
10. Tolerability of the investigational study product
11. Any serious organ or systemic diseases
12. Eating disorder
13. Extensive exercise
14. Genetic hyperlipidemia
15. Drug or alcohol abuse
16. Active weight loss > 5 kg in prior 3 months participation in other studies within the last 30 days /
during the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified