Effect of probiotic yoghurt on the blood cholesterol levels of healthy volunteers

Not Applicable

Completed

• Conditions: Elevated LDL cholesterol levels; Circulatory System

• Registration Number: ISRCTN12076381
• Lead Sponsor: BioCC OÜ

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36437811/ (added 20/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-04-01
• Study Start: 2021-12-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

1. A written informed consent
2. Aged between 18 - 65 years
3. No personally known health problems
4. 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) 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)
8. LDL-cholesterol values =3.0 mmol/l– 5.3 mmol/l

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