Study to evaluate the efficacy of processed oil in adult subjects

Not Applicable

• Registration Number: CTRI/2016/08/007158
• 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: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

• Patients of either sex in the age group between 25 to 60 years

• LDL levels (>=130 mg/dL and <190mg/dL)

• Patient with body mass index of >= 23 kg/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 systolic and/or >=100 mm Hg diastolic)

• Participants on Medication/special diets for weight loss

• Current smoker

• Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week.

• 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

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of Interesterified dietary fat on Optimal weight management.Timepoint: 45 Days from Baseline Visit

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of Interesterified dietary fat on following parameters: <br/ ><br>â?¢ Calorie content of food and Stool energy loss Total cholesterol, LDL-Cholesterol, HDL-Cholesterol and Triglycerides. <br/ ><br>â?¢ Body Mass Index, Body composition i.e. Fat mass, Fat free mass, Body fat (%) and Body Adiposity Index. <br/ ><br>â?¢ C-Peptide, Glucose (Random) and Insulin. <br/ ><br>â?¢ Leptin and Adiponectin.Timepoint: 45 Days from Baseline Visit