Study to evaluate the efficacy of a blend of rice bran oil and safflower oil (7:3) with antioxidants in comparison with olive oil in adult hyperlipidemic subjects.

A randomized, double blind, parallel group, proof of concept study to evaluate the efficacy of a blend of rice bran oil and safflower oil (7:3) with antioxidants in comparison with olive oil in adult hyperlipidemic subjects. - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/05/004579

Enrollment

172

Registered

2014-05-02

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: A blend of rice bran oil and safflower oil (7:3) with antioxidants: Subjects will be provided with the food prepared in blend of rice bran oil and safflower oil (7:3). Dose: 1 litre/sub

Eligibility

Inclusion criteria

Inclusion criteria: • LDL levels ( >= 130 mg/dL and • hsCRP >1 mg/L • Patient with body mass index of >18.5kg/m 2 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. • Poorly controlled hypertension (resting blood pressure >=160 mm Hg and systolic and/or >=100 mm Hg diastolic). • Uncontrolled hypothyroidism or thyroid stimulating hormone • Recent history (past 12 months) of drug abuse or alcohol abuse. Alcohol abuse will be defined as >14 drinks per week. • Current smoker • 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 treatment.Timepoint: 105 Days from Baseline Visit	—

Secondary

Measure	Time frame
To evaluate the effect of treatment on following parameters such as TC, HDL, VLDL, TG,polipoprotein B, Apolipoprotein A, hsCRP, ox LDL, Superoxide dismutase, HbA1c, BMI,body fat composition and waist circumferenceTimepoint: 105 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