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

Phase 3

Completed

• Conditions: Hyperlipidemia
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules)

• Registration Number: NCT02187757
• Lead Sponsor: PreEmptive Meds, Pvt. Ltd

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-10
• Study First Posted: 2014-07-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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:

1. Age ≥ 18 years to ≤ 65 years
2. LDL cholesterol levels >120mg/dl
3. 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

1. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris in the past.

2. Cardiac status New York Heart Association class III-IV

3. Uncotrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic

4. 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

5. Clinically significant peripheral edema

6. 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)

7. Participants on steroid

8. Pregnancy or lactating women

9. Known hypersensitivity to any of the study drugs

10. 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.

11. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years

12. 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

13. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.

14. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study

15. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the studyevaluation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 600 mg capsules	Placebo	Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.
PreLipid	Study Dietary Supplement (Prelipid 500 mg capsules)	Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90days along with lifestyle modification.

Primary Outcome Measures

Name	Time	Method
Safety of Dietary Supplement PreLipid 600 mg twice-daily	Day 1(Baseline) to Day 90 (End of Study)	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)
Efficacy of Dietary Supplement PreLipid 600 mg twice-daily in lowering LDL-C levels	Day 1 (Baseline) to Day 90 (End of Study)	Change in LDL-C % from baseline (Day 1) to the end of supplementation/treatment after 90 days

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Singvi Health Centre; 🇮🇳 Chennai, Tamil Nadu, India

Fortis Escorts Hospital; 🇮🇳 Jaipur, Rajasthan, India

Rangammal Hospital; 🇮🇳 Tiruvannamalai, Tamil Nadu, India

Division of Clinical & Preventive Cardiology, Heart Institute; 🇮🇳 Gurgaon, Delhi, India

Pace Clinical Research Center; 🇮🇳 Bangalore, Tamil Nadu, India

Dr. Vikas Govind Pai Clinical Research Foundation; 🇮🇳 Pune, Maharashtra, India

Life Care Institute of Medical Science & Research; 🇮🇳 Ahmedabad, Gujarat, India

Bhatia Hospital Medical Research Society; 🇮🇳 Mumbai, Maharashtra, India