Impact of Rapeseed and Sunflower Oils on Proteomic Biomarkers of Diseases. (DOC)

April 27, 2021 updated by: Emilie Combet, University of Glasgow

No Evidence of Impact of Seed Oil Intake on Biomarkers of Coronary Artery Disease, Chronic Kidney Disease and Diabetes in Healthy Adults With Overweight and Obesity - Result From a Blinded Randomised Control Trial

This study will test the impact of vegetable oils with contrasting fatty acids composition on biomarkers of health (cardiovascular, kidney diseases and diabetes) after twelve weeks supplementation. We will use sunflower oil (high in PUFAs), rapeseed oil (high in MUFAs, locally produced) and a non-intervention control. We have developed a sensitive and selective urinary proteomic biomarker of cardiovascular disease which we will use in a double-blinded randomised study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The intervention follows a parallel double-blind randomised control design. The intervention duration is 12 weeks, with a mid-point assessment at 6 weeks. Randomisation to groups; rapeseed oil, sunflower oil or habitual diet is performed using a block stratified allocation based on age (under or over 45) and BMI (under or over 30kg/m2) and is carried out remotely via phone.

Participants allocated to either oil groups are instructed to consume the oils uncooked, as a partial replacement to their habitual fat intake. Participants in the control group are asked to not change any aspect of their diet.

Spot urine samples are collected from all participants at all time points for measurement of the primary outcome (proteomic biomarker score). Urine is collected in a plastic tube, mid-flow, as the second urination of the day at baseline, 6 and 12 weeks.

Fasting venous blood is collected for the assessment of secondary outcomes, at baseline, 6 weeks and 12 weeks. Participants are also asked to complete a 2-day food diary at weeks 0, 6 and 12

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 8QE
        • University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Overweight adults with a BMI>25 and/or a large waist (Male >102cm and female >88cm),
  • Aged 25-75 years
  • No history of chronic disease of the GI tract
  • Not taking medication (other than the contraceptive pill).

Exclusion Criteria:

  • Pregnant or lactating
  • Allergy to any vegetable oils and vegetable oil-derived products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rapeseed oil
Participants asked to consume 20mL of rapeseed oil raw every day for 12 weeks
Dietary supplement: Rapeseed oil
20mL of rapeseed oil to be consumed daily in replacement to habitual oil
Other Names:
  • RO
Active Comparator: Sunflower oil
Participants asked to consume 20mL of sunflower oil raw every day for 12 weeks
Dietary supplement: Sunflower oil
20mL of sunflower oil to be consumed daily in replacement to habitual oil
Other Names:
  • SO
No Intervention: Habitual diet
Participants asked to maintain their habitual diet for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proteomic biomarkers
Time Frame: 0, 6, 12 weeks
Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)
0, 6, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood lipids
Time Frame: 0, 6, 12 weeks
Changes in concentrations of plasma glucose, triglycerides, total cholesterol, high density lipoprotein,
0, 6, 12 weeks
Inflammation markers
Time Frame: 0, 6, 12 weeks
Changes in concentrations of plasma interleukin 6, tumor necrosis factor, matrix metallopeptidase 9
0, 6, 12 weeks
Oxidative stress biomarkers
Time Frame: 0, 6, 12 weeks
Changes in concentrations of plasma fructosamine, AGE, RAGE
0, 6, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 27, 2021

First Posted (Actual)

April 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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