Clinical study to evaluate the efficacy of 2 test oils in comparison with routinely consumed oil in adult hyperlipidemic subjects

Phase 4

Completed

• Conditions: Health Condition 1: null- Hyperlipidemic

• Registration Number: CTRI/2014/07/004735
• Lead Sponsor: Spectrum Clinical Research Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified