Effect of probiotic yoghurt (L. plantarum strain INDUCIA) on healthy volunteers

Phase 2

Completed

• Conditions: Elevated LDL cholesterol levels; Nutritional, Metabolic, Endocrine; Pure hypercholesterolaemia

• Registration Number: ISRCTN26344255
• Lead Sponsor: BioCC OÜ

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-03-26
• Study Completion: 2012-04-25
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. A significant reduction in blood LDL-cholesterol between probiotic and placebo group after 4 and 8 weeks of product intake<br> 2. The first primary end point: reduction in blood LDL-cholesterol in probiotic group after 4 weeks of product intake<br> 3. The second primary end point: reduction in blood LDL-cholesterol in probiotic group after 8 weeks of product intake<br><br> Measured at baseline, at 4th week from the beginning of the trial, and at 8th week from the beginning of the trial<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. In probiotic group maintenance or significant (p<0.05) reduction of:<br> 1.1. Cholesterol/HDL-cholesterol ratio<br> 1.2. LDL/HDL-cholesterol ratio, triglycerides<br> 1.3. HLD-cholesterol<br> 1.4. Adiponectin levels 8-isoprostanes<br> 1.5. oxLDL-cholesterol<br> 1.6. Leptin<br> 1.7. IL-6<br> 1.8. TNFa<br> 1.9. HbA1c<br> 1.10. OSI<br> 2. Maintenance or significant (p<0.05) increase of:<br> 2.1. HDL-cholesterol<br> 2.2. Ca<br> 2.3. iCa<br> 2.4. Vitamin D<br><br> Measured at baseline, at 4th week from the beginning of the trial, and at 8th week from the beginning of the trial<br>