Effect of probiotic yoghurt comprising L. plantarum strain Inducia on healthy volunteers randomized blinded controlled parallel-designed two-armed study

BioCC OÜ0 个研究点目标入组 200 人开始时间: 2012年3月26日最近更新: 2023年1月9日

试验速览

2022 Results article in https://doi.org/10.1016/j.jff.2022.105064 (added 16/12/2022)

•1. A written informed consent
•2. Aged between 18 - 65 years
•3. No personally known health problems
•4. Elevated levels of blood total cholesterol/cholesterol fractions: =3.0 mmol/l for LDL, =3.0 mmol/l for LDL/HDL ratio, =5.0 mmol/l for total cholesterol and =1.7 mmol/l for 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 and acute infection within the last 2 weeks prior to enrolment
•3. 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
•4. Intolerance to the investigational product/its ingredients
•5. Any kind of concurrent disease which could influence the evaluation of the efficacy and the tolerability of the investigational study product
•6. Any serious organ or systemic diseases
•7. High blood pressure (e.g., >140/95 mmHg)
•8. Eating disorder
•9. Extensive exercise
•10. Genetic hyperlipidemia
•11. Drug or alcohol abuse
•12. Active weight loss > 5 kg in prior 3 months
•13. Participation in other studies within the last 30 days/during the study

发起方

BioCC OÜ