Effects of Corn Oil Plus Vitamin E and B6 on LIpids, PcSk9 and Endothelial Function

NCT03005535 | Unknown DMC

• 1 other identifier: ECLIPSE_2016
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized clinical trial carried out on subjects with suboptimal control of cholesterolemia who will consume 30 g per day of a vitaminized corn oil (plus B6 and E vitamins), in order to evaluate the effects on lipid profile, endothelial function and PCSK9

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (3)

• Endothelial function (measured by Endocheck) change from the baseline to the end of the intervention period

  At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)

• 12 hour fasting lipid profile change from the baseline to the end of the intervention period

  At the first visit (run-in) at the beginning, after 4 and 8 weeks of both intervention periods (up to 24 weeks)

• PCSK9 levels change from the baseline to the end of the intervention period

  At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)

Secondary Outcomes (3)

• Inflammatory markers (high sensitivity C reactive protein hs-PCR, malondialdehyde MDA, homocysteine) change from the baseline to the end of the intervention period

  At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)

• Blood pressure change from the baseline to the end of the intervention period

  6 months

• Fatty acid profile of whole blood total lipids change from the baseline to the end of the intervention period

  At the beginning and after 8 weeks of both intervention periods (up to 24 weeks)

Study Arms (2)

Vitaminized corn oil

ACTIVE COMPARATOR

Vitaminized corn oil (plus B6 and E vitamins), 30 g per day, per 8 weeks, with meals (15 g per meal)

Other: Vitaminized corn oil

Olive oil

PLACEBO COMPARATOR

Olive oil (not extra-virgin), 30 g per day, per 8 weeks, with meals (15 g per meal)

Other: Olive oil

Interventions

Vitaminized corn oil OTHER

Oil consumption at the two main meals, lunch and dinner (15gx2 per day)

Vitaminized corn oil

Olive oil OTHER

Oil consumption at the two main meals, lunch and dinner (15gx2 per day)

Olive oil

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Total cholesterol between 200 and 280 mg/dL and/or LDL cholesterol between 130 and 190 mg/dL
• Triglycerides lower than 200 mg/dL
• Cardiovascular risk at 10 years lower than 10%
• Informed consent

You may not qualify if:

• Secundary prevention for cardiovascular diseases
• BMI higher than 30
• Assumption of lipid lowering drug or supplement
• Alcohol abuse
• Alterations in thyroid, liver or kidney functions, muscle diseases

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

S. Orsola-Malpighi University Hospital

Bologna, BO, 40138, Italy

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Olive Oil

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Internal Medicine Unit

Study Record Dates

• First Submitted: December 5, 2016
• First Posted: December 29, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 29, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)