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

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

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Study Dietary Supplement (Prelipid 500 mg capsules)

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Delhi
    • Gurgaon, Delhi, India, 122001
      • Division of Clinical & Preventive Cardiology, Heart Institute
  • Gujarat
    • Ahmedabad, Gujarat, India, 380014
      • Life Care Institute of Medical Science & research
  • Maharashtra
    • Mumbai, Maharashtra, India, 400007
      • Bhatia Hospital Medical Research Society
    • Pune, Maharashtra, India, 411005
      • Dr. Vikas Govind Pai Clinical Research Foundation
  • Rajasthan
    • Jaipur, Rajasthan, India, 302017
      • Fortis Escorts Hospital
  • Tamil Nadu
    • Bangalore, Tamil Nadu, India, 560043
      • Pace Clinical Research Center
    • Chennai, Tamil Nadu, India, 600079
      • Singvi Health Centre
    • Tiruvannamalai, Tamil Nadu, India, 606003
      • Rangammal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PreLipid; 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); 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.; Other Names: PreLipid, Natural Cholesterol Supplement, Predisease
PLACEBO_COMPARATOR: Placebo 600 mg capsules; Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.	Dietary supplement: Placebo; Other Names: Placebo 600 mg capsules

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of Dietary Supplement PreLipid 600 mg twice-daily with Kidney Function	Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to End of Study (Day 90); Serum Creatinine from baseline (Day 1) to End of Study (Day 90)	Baseline (Day 1) to End of Study (Day 90)

Collaborators and Investigators

• Sponsor: PreEmptive Meds, Pvt. Ltd
• Collaborators: Abbott
• Investigators: Study Chair: Ravi Kasliwal, MD, DM, FIMSA, Medanta, The Medicity, India

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: June 30, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (ESTIMATE): July 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): May 15, 2015
• Last Update Submitted That Met QC Criteria: May 14, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Dyslipidemia; Triglycerides; High cholesterol; High LDL
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias
• Other Study ID Numbers: Prelip/Nutra001/PMI13