Status:
COMPLETED
The Cholesterol-lowering Efficacy of Probiotic Lactobacillus Plantarum in Hypercholesterolaemic Adults
Lead Sponsor:
University of Roehampton
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Coronary heart disease (CHD) is one of the major causes of death and disability in industrialised countries. Results from several epidemiological and clinical studies indicate a positive correlation b...
Detailed Description
The aim of this human volunteer study was to establish tolerance, and the extent of the cholesterol lowering potential of Lactobacillus plantarum ECGC 13110402 in 49, healthy, normal to mildly hyperch...
Eligibility Criteria
Inclusion
- aged between 18 and 50 years of age.
- in good general health, defined as no comorbidities requiring regular
- medical follow up
- ability to communicate well with the investigator and to comply with the
- requirements of the entire study
- BMI 18.5 to 29.9 kg/m2
- total cholesterol (TC) between 200 and 300 mg/dl (5.16 and 7.64 mmol/L).
Exclusion
- History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- Consumed probiotic or prebiotic preparations on a regular basis (at least 3
- times per week) in the last 2 weeks and during the trial period
- Former participation in another study involving prebiotic or probiotic
- preparations or investigational drugs within the previous 6 months, or
- intention to use such drugs during the course of the study
- high blood cholesterol or use of cholesterol lowering drugs
- Undergone surgical resection of any part of the bowel
- History of malignancy within the previous 5 years (with exception of well-
- treated basal cell carcinoma or in situ cervical carcinoma).
- Currently prescribed immunosuppressive drugs
- Intention to use regularly other medication which affects gastrointestinal
- motility and/or perception
- Current or recent history (within 12 months) of significant drug or alcohol
- abuse or dependence
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03263104
Start Date
January 1 2015
End Date
August 1 2015
Last Update
August 28 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.