Effect of kefir containing probiotic Lactobacillus fermentum ME-3 on healthy volunteers

Phase 2

Completed

Conditions: Elevated values of blood triglycerides, blood cholesterol and its fractions
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN49744186

Lead Sponsor: Tere AS (Estonia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 140

Inclusion Criteria

1. A written informed consent
2. Age between 35 and 65 years
3. No known health problems
4. Elevated levels of blood total cholesterol/cholesterol fractions: >3.4 mmol/l for LDL, >3.0 mmol/l for the LDL/HDL ratio, >5.2 mmol/l for the total cholesterol and >1.7mmol/l for the level of triglycerides
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, soy protein, psyllium seed husk or probiotics/prebiotics within the preceding 2 months
6. Willingness to maintain a stable diet and physical activity level
7. Normal or not clinically pronounced safety lab values (clinical chemistry, blood count) except for lipids

Exclusion Criteria

1. Pregnancy and breastfeeding
2. A history of gastrointestinal disease, food allergy, diabetes
3. Acute infection within the last 2 weeks prior to enrolment
4. Use of any antimicrobial agents within the preceding 2 months or use of any regular concomitant medication including any non-steroidal anti-inflammatory drugs and antioxidant products 2 weeks
5. Intolerance to the investigational product / its ingredients
6. Any kind of concurrent disease which could influence the evaluation of the efficacy and the tolerability of the investigational study product
7. Any serious organ or systemic diseases
8. High blood pressure (e.g. >140/95 mm Hg)
9. Eating disorder
10. Extensive exercise
11. Genetic hyperlipidemia
12. Drug or alcohol abuse
13. Active weight loss > 5 kg in prior 3 months
14. Participation in other studies within the last 30 days / during the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiovascular health:<br>1. Significant decrease of LDL-cholesterol <br>2. Significant decrease of triglycerides<br><br>Protection against oxidative damage:<br>1. Significant decrease of oxidized LDL <br>2. Significant decrease of urinary isoprostanes

Secondary Outcome Measures

Name	Time	Method
Cardiovascular health:<br>In probiotic group maintenance or significant reduction (p<0.05) of: <br>1. HDL-cholesterol<br>2. Homocysteine<br>3. ApoB/apoA1<br>4. hs-CRP<br>5. Leptin <br>6. Adiponectin<br>7. Blood pressure<br><br>Protection against oxidative damage:<br>In probiotic group maintenance or significant reduction (p<0.05) of: <br>1. Oxidative stress index (OSI) <br>2. Glutathione redox status (GSSG/GSH)<br>3. MPO<br>4. IL-6<br>5. TNF-alpha<br><br>Temporal colonization of GI tract with L. fermentum ME-3 detected in faecal samples.<br><br>Measured at baseline, at the 4th week and the 8th week from the beginning of the trial.