NCT04867629

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

April 27, 2021

Last Update Submit

April 27, 2021

Conditions

Cardiovascular Diseases

Keywords

rapeseed oilsunflower oilproteomicscardiometaboliccardiovascularfatty acidsmonounsaturated fatty acidsseed oilsdietary fat

Outcome Measures

Primary Outcomes (1)

  • Proteomic biomarkers

    Changes in proteomic biomarker scores of coronary artery disease (CAD238), chronic kidney disease (CKD273)

    0, 6, 12 weeks

Secondary Outcomes (3)

  • Blood lipids

    0, 6, 12 weeks

  • Inflammation markers

    0, 6, 12 weeks

  • Oxidative stress biomarkers

    0, 6, 12 weeks

Study Arms (3)

Rapeseed oil

EXPERIMENTAL

Participants asked to consume 20mL of rapeseed oil raw every day for 12 weeks

Dietary Supplement: Rapeseed oil

Sunflower oil

ACTIVE COMPARATOR

Participants asked to consume 20mL of sunflower oil raw every day for 12 weeks

Dietary Supplement: Sunflower oil

Habitual diet

NO INTERVENTION

Participants asked to maintain their habitual diet for 12 weeks

Interventions

Rapeseed oilDIETARY_SUPPLEMENT

20mL of rapeseed oil to be consumed daily in replacement to habitual oil

Also known as: RO
Rapeseed oil
Sunflower oilDIETARY_SUPPLEMENT

20mL of sunflower oil to be consumed daily in replacement to habitual oil

Also known as: SO
Sunflower oil

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Glasgow

Glasgow, Scotland, G12 8QE, United Kingdom

Location

Related Publications (1)

  • Nicol K, Mansoorian B, Latosinska A, Koutroulaki A, Mullen B, Combet E. No evidence of differential impact of sunflower and rapeseed oil on biomarkers of coronary artery disease or chronic kidney disease in healthy adults with overweight and obesity: result from a randomised control trial. Eur J Nutr. 2022 Sep;61(6):3119-3133. doi: 10.1007/s00394-022-02810-5. Epub 2022 Apr 5.

    PMID: 35381848DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Rapeseed OilSunflower Oil

Intervention Hierarchy (Ancestors)

Plant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Oils were in identical amber glass bottles labelled A or B. Oils blinded to participants and investigators. However, the control group was unblinded due to them not receiving any intervention
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized, double-blind, placebo-controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer

Study Record Dates

First Submitted

April 27, 2021

First Posted

April 30, 2021

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 30, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)