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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/07/004735

Enrollment

Registered

2014-07-14

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

Health Condition 1: null- Hyperlipidemic

Interventions

Intervention1: 2 test oils (processed and unprocessed): Subjects will be provided with the food prepared in either processed or unprocessed oil. Dose: 1 litre/subject/month, Frequency: Three times a d

Eligibility

Inclusion 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 ( • Patient with body mass index of >18.5kg/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 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

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of treatment on LDLâ??C level in comparison with the control treatmentTimepoint: 30 Days from Baseline Visit	—

Secondary

Measure	Time frame
To evaluate the effect of treatment on following parameters such as TC, HDL, VLDL, TG, blood glucose, BMI, body fat composition and waist circumferenceTimepoint: 30 Days from Baseline Visit	—

Countries

India

Contacts

Public ContactMr Sushil Singh

Spectrum Clinical Research Pvt. Ltd.

ssingh@spectrumcr.com02240645100

Outcome results

None listed

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