Health Condition 1: I70-I79- Diseases of arteries, arterioles and capillaries
Conditions
Interventions
Intervention1: ColRed+Probiotic: 15 gms of product twice a day in luke warm water or milk for 2 months
Intervention2: ColRed+Probiotic: 30 gms once a day in luke warm water or milk for 2 months
Cont
Sponsors
British Biologicals
Eligibility
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?? The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-Cholesterol Timepoint: At week 2, week 4 and and week 8(study end). | — |
Secondary
| Measure | Time frame |
|---|---|
| â?? Change in other lipid levels (total cholesterol, HDL-cholesterol and triglyceride) â?? Incidence of adverse events â?? Quality of life assessment of the subjects â?? Feedback with regard to product taste and consumption habits Timepoint: At week 2, week 4 and and week 8(study end). | — |
Countries
India
Contacts
Public ContactDr Manjunath
ICBio Clinical Research Pvt. Ltd.
Outcome results
None listed