Effect of kefir containing probiotic L. fermentum ME-3 on blood indices of healthy volunteers in a randomized double-blinded controlled parallel-designed two-armed study

Tere AS (Estonia)0 个研究点目标入组 140 人开始时间: 2014年2月5日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

Tere AS (Estonia)