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Study to evaluate the efficacy of processed oil in adult subjects

An open label, single arm, proof of concept study to evaluate the efficacy of processed oil in adult subjects - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/08/007158
Enrollment
30
Registered
2016-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Processed oil: Subjects will be served food prepared from processed oil. Dose: 1 litre/subject/month, Frequency: Three times a day, Duration: 45 days and Route Of Adminitration: Oral Co

Sponsors

Spectrum Clinical Research Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients of either sex in the age group between 25 to 60 years • LDL levels (>=130 mg/dL and • Patient with body mass index of >= 23 kg/m2 and • Untreated Dyslipidemia • Willingness to maintain current activity levels and follow the prescribed diet

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of Interesterified dietary fat on Optimal weight management.Timepoint: 45 Days from Baseline Visit—

Secondary

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

Countries

India

Contacts

Public ContactDr Sonali Ghosh

Spectrum Clinical Research Pvt. Ltd.

sghosh@specrtumcr.com02240645100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026