MedDataX Logo

Impact of Rapeseed and Sunflower Oils on Proteomic Biomarkers of Diseases.

NCT ID: NCT04867629

Last Updated: 2021-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

rapeseed oil sunflower oil proteomics cardiometabolic cardiovascular fatty acids monounsaturated fatty acids seed oils dietary fat

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, double-blind, placebo-controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rapeseed oil

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

Group Type EXPERIMENTAL

Rapeseed oil

Intervention Type DIETARY_SUPPLEMENT

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

Sunflower oil

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

Group Type ACTIVE_COMPARATOR

Sunflower oil

Intervention Type DIETARY_SUPPLEMENT

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

Habitual diet

Participants asked to maintain their habitual diet for 12 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rapeseed oil

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

Intervention Type DIETARY_SUPPLEMENT

Sunflower oil

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RO SO

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Glasgow

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Emilie Combet

Senior lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Glasgow

Glasgow, Scotland, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 35381848 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DOC

Identifier Type: -

Identifier Source: org_study_id