Study to Evaluate Efficacy and Safety of PreLipid® on Subjects With Higher Than Normal Blood Lipid Levels

Study Overview
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Brief Summary
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Study to evaluate Efficacy and Safety of PreLipid® on subjects with higher than normal blood lipid levels

Detailed Description
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A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the safety, efficacy and tolerability of PreLipid®, a twice-daily nutritional supplement in subjects with higher than normal blood lipid levels

Official Title
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A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, Study to Evaluate the Safety, Efficacy and Tolerability of PreLipid®, a Twice-daily Nutritional Supplement in Subjects With Higher Than Normal Blood Lipid Levels

Conditions
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Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed Male or Female participants with higher than normal cholesterol levels defined by the American Heart Association, National Cholesterol Education Program (NCEP) and ATP-III goals for LDL cholesterol and cut off points for therapeutic lifestyle changes (TLCs) and drug therapy in different risk categories: Age ≥ 18 years to ≤ 65 years LDL cholesterol levels >120mg/dl Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures - Exclusion Criteria: Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past. Cardiac status New York Heart Association class III-IV Uncotrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female Clinically significant peripheral edema Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN) Participants on steroid Pregnancy or lactating women Known hypersensitivity to any of the study drugs Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PreLipid<br>Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90days along with lifestyle modification. | Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules)<br>* Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.<br>* Other names: PreLipid, Natural Cholesterol Supplement, Predisease;|
| Placebo Comparator: Placebo 600 mg capsules<br>Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program. | Dietary Supplement: Placebo<br> <br> * Other names: Placebo 600 mg capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels | Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days | Day 1 (Baseline) to Day 90 (End of Study) | 
| Safety of Dietary Supplement PreLipid 600 mg twice-daily | Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day 1) to End of Study (Day 90) and Alkaline Phosphatase (ALP) from baseline (Day 1) to End of Study (Day 90) | Day 1(Baseline) to Day 90 (End of Study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Glycemic Status | To assess percentage changes in Blood Sugar profile (HbA1c) from baseline to at the end of supplementation after 03 months. | Day 1 (Baseline) to Day 90 (End of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dyslipidemia, High cholesterol, High LDL, Triglycerides