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

University of Glasgow

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Dietary Supplement: Rapeseed oil; Dietary Supplement: Sunflower oil

Study type: Interventional

Funder types: Other

Identifiers

NCT04867629

DOC

Details and patient eligibility

About

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.

Full 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

Enrollment: 84 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 3 patient groups

Rapeseed oil

Experimental group

Description:

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

Treatment:

Dietary Supplement: Rapeseed oil

Sunflower oil

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Sunflower oil

Habitual diet

No Intervention group

Description:

Participants asked to maintain their habitual diet for 12 weeks