Status:
ACTIVE_NOT_RECRUITING
Efficacy of Cholesterol-lowering L. Plantarum on Cardiometabolic Health Biomarkers in Coeliac Disease Patients
Lead Sponsor:
University of Roehampton
Conditions:
Celiac Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Recent studies have also shown that 30% of the world's population carries the susceptibility genes for coeliac disease and that only 2-5% of these individuals are really affected, however, studies sug...
Detailed Description
A total of 50 coeliac subjects (+/- 6 additional volunteers) will be recruited to achieve statistical significance with changes on a logarithmic scale of 1.2 for cholesterol based on other interventio...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Adults aged between 18 and 65 years, with CD Diagnosis
- Fasting blood glucose level not above 5.6-6.9mmol/L
- High baseline cholesterol (TC\> 6mmol / L).
- HbA1c below 5.7%
- With cholesterol
- For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.
- Exclusion criteria
- People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, uncontrolled hypertension, cancer or major psychiatric or cognitive problems
- People who are already participating in a weight loss programme
- People receiving drug treatment for lipid metabolisms (e.g., statins
- People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids)
- People with elevated liver enzymes (alanine aminotransferase ≥300 IU/L, aspartate aminotransferase ≥300 IU/L)
- People who take antibiotics or bacterial agents (Probiotics) within 1 month
- Pregnant women, women ready for pregnancy, and nursing mothers
- All capsules (probiotic and placebo) have the same taste and appearance and have been mixed, encapsulated and packaged to ensure product consistency throughout the study. All capsules will be distributed free of charge to participants in this study.
Exclusion
Key Trial Info
Start Date :
April 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06178107
Start Date
April 12 2022
End Date
December 21 2025
Last Update
December 9 2024
Active Locations (2)
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1
Uoc Di Gastroenterologia Aou S. Giovanni Di Dio E Ruggi D'Aragona
Salerno, Italy, 84131
2
Health Sciences Research Centre, Life Sciences Department, University of Roehampton
London, UK, United Kingdom, SW15 4JD