CTRI/2014/07/004735CompletedPhase 4
A randomized, pilot, double blind, parallel group, proof of concept study to evaluate the efficacy of 2 test oils (processed and unprocessed) in comparison with routinely consumed oil in adult hyperlipidemic subjects - Nil
Spectrum Clinical Research Pvt Ltd0 sites36 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 36
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Hyperlipidemic subjects having LDL-C level between 130 - 190 mg/dl (excluded are LDL-C levels between 160 and 190 mg/dl and also having other two or more cardiac risk factors as defined in Adult Treatment Panel III [e.g. obesity (BMI > 30 kg / m2), low HDL-C ( < 40%), hypertension, diabetes, smoking etc.)
- •Patient with body mass index of >18.5kg/m2 and < 30 kg/m2
- •Untreated Dyslipidemia
- •Willingness to maintain current activity levels and follow the prescribed diet
Exclusion Criteria
- •Use of oral or injected corticosteroids or anabolic steroids at Visit 1 or prior to randomization
- •Uncontrolled hypothyroidism
- •Poorly controlled hypertension (resting blood pressure >=160 mm Hg and systolic and-or >=100 mm Hg diastolic).
- •Current smoker
- •Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week (1 drink equal to 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
- •Exposure to any investigational product within 4 weeks prior to Visit 1, or prior to randomization
- •Women who are pregnant, lactating, or planning to become pregnant.
- •Liver disorders.
- •Taking lipid lowering drugs
- •Congestive cardiac failure, acute myocardial infarction within last 1 month
Investigators
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