A clinical study to find the efficacy of Probiotic with Col-Red compared with Col-Red alone on reducing cholesterol in patients with hypercholesterolemia.
- Conditions
- Health Condition 1: I70-I79- Diseases of arteries, arterioles and capillaries
- Registration Number
- CTRI/2012/06/002722
- Lead Sponsor
- British Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
•A total of 30 Subjects aged between 18-65 years with known but untreated moderate hypercholesterolemia.
•Subjects diagnosed with total cholesterol equal to or above 200 mg/dl and who have LDL-cholesterol levels equal to or above 130 mg/dl
•Subjects who give their consent to participate after being informed of the study objectives
•Severe disease necessitating pharmacological intervention
•Hepatic disease, gastrointestinal complaints and gastrointestinal ulcers.
•Thyroid dysfunction or any kidney disease;
•Personal history of cardiovascular illness
•Uncontrolled diabetes and uncontrolled hypertension in terms of the WHO criteria (140/90 mmHg)
•Known food allergy.
•Significant chronic organic or psychiatric disease
•Not obtaining informed consent
•Pregnant or lactating subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â??The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-Cholesterol <br/ ><br>Timepoint: At week 2, week 4 and and week 8(study end).
- Secondary Outcome Measures
Name Time Method â??Change in other lipid levels (total cholesterol, HDL-cholesterol and triglyceride) <br/ ><br>â??Incidence of adverse events <br/ ><br>â??Quality of life assessment of the subjects <br/ ><br>â??Feedback with regard to product taste and consumption habits <br/ ><br>Timepoint: At week 2, week 4 and and week 8(study end).