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

PreEmptive Meds

Status and phase: Completed; Phase 3

Conditions: Hyperlipidemia

Treatments: Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187757

Prelip/Nutra001/PMI13

Details and patient eligibility

About

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

Full 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

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups, including a placebo group

PreLipid

Experimental group

Description:

Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90days along with lifestyle modification.

Treatment:

Dietary Supplement: Study Dietary Supplement (Prelipid 500 mg capsules)

Placebo 600 mg capsules

Placebo Comparator group

Description:

Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

Treatment:

Dietary Supplement: Placebo