A clinical trial to study different brands of blended edible vegetable oils in Hyperlipidemic, Pre-diabetic subjects with normal blood pressure.

Multicentric, randomized, four arm, double blind, parallel group study in adult hyperlipidemic, Preâ??diabetic and Normotensive subjects. - SCR/022/SGO/2018

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/03/017953

Enrollment

236

Registered

2019-03-06

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: Blended Edible vegetable oil Test blend 1 ( blend of rice bran oil and sunflower oil (7:3) with antioxidant): Subjects will be provided with food prepared in blended edible oil (Test bl

Eligibility

Inclusion criteria

Inclusion criteria: 1. LDL Cholesterol levels 130-189mg/dl (ATP III Guidelines) 2. Patient with body mass index of >=23 kg/m2 and 3. Untreated Dyslipidemia 4. Willingness to maintain current activity levels and follow the prescribed diet

Exclusion criteria

Exclusion criteria: 1. Use of oral or injected corticosteroids or anabolic steroids 3 months prior/during the study 2. Uncontrolled thyroidism 3. Poorly controlled hypertension (resting blood pressure >=140 mm Hg systolic and/or >=90 mm Hg diastolic) 4. Participants on Medication/ alternative medicine/special diets for weight loss 5. Current smoker 6. Women who are pregnant, lactating, or planning to become pregnant 7. Liver disorders

Design outcomes

Primary

Measure	Time frame
To evaluate the effect of treatment on LDL-C levels in comparison with all four groups.Timepoint: 90 days from Baseline Visit.	—

Secondary

Measure	Time frame
To evaluate the effect of treatment on following parameters such as TC, TG, HDL, VLDL, oxLDL, hsCRP, HbA1C, Fasting & PP sugar Systolic & Diastolic BP, Mean Arterial Pressure, BMI,Waist Circumference & quality of life.Timepoint: 90 days from Baseline Visit.	—

Countries

India

Contacts

Public ContactDr Sonali Ghosh

Medical Monitor

vgaikwad@spectrumcr.com02240645100

Outcome results