Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867629
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2021-04-27
Brief Title:
Impact of Rapeseed and Sunflower Oils on Proteomic Biomarkers of Diseases
Sponsor:
University of Glasgow
Organization:
University of Glasgow
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOC
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
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 30kgm2 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None