The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial (INTER-CARDIO)
|ClinicalTrials.gov Identifier: NCT03438084|
Recruitment Status : Completed
First Posted : February 19, 2018
Last Update Posted : January 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Healthy Adults||Dietary Supplement: Interesterified fat Dietary Supplement: Non- interesterified fat Dietary Supplement: Rapeseed oil Dietary Supplement: Butter||Not Applicable|
Aim: The current study aims to investigate the acute effects of commercially available interesterified fat versus versus application appropriate non- interesterifed alternative fat on 8 h postprandial cardiometabolic outcomes.
Hypothesis: Interesterified fat will induce a different cardiomtabolic response compared to a non interesterifed, application appropriate fat.
Subjects: Participants will include 40 healthy male and female volunteers aged between the ages of 35 and 75 years (since during this age metabolic changes start to take place).
Power calculation: Based on previous studies carried out by our group at King's College London, a sample size of 20 participants (males and females separately) will allow a 2.16% (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50 participants will be recruited allowing for a 20% dropout rate.
Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular|
|Actual Study Start Date :||July 1, 2018|
|Actual Primary Completion Date :||October 1, 2019|
|Actual Study Completion Date :||October 31, 2019|
Commercially available interesterifed fat spread. 50g fat.
Dietary Supplement: Interesterified fat
50 g fat provided as commercially available interesterified fat.
Active Comparator: Non- interesterified
Commercially available non-interesterified fat. 50g fat.
Dietary Supplement: Non- interesterified fat
50 g fat provided as commercially available non-interesterified fat.
Active Comparator: Control
Rapeseed oil. 50 g fat.
Dietary Supplement: Rapeseed oil
50 g fat provided as commercially available rapeseed oil.
Active Comparator: Saturated fat control
Butter. 50g fat
Dietary Supplement: Butter
50g fat provided as commercially available spreadable butter
- Endothelial function [ Time Frame: Up to 8 hours ]Flow mediated dilatation
- Postprandial lipaemic response [ Time Frame: Up to 8 hours ]Area under plasma TAG concentration/ time curve
- Postprandial lipaemic response [ Time Frame: Up to 8 hours ]Postprandial plamsa total fatty acid composition and non esterifed fatty acid
- Metabolomic for assessment of atherogenic potential (lipoprotein) analysis [ Time Frame: Up to 8 hours ]Lipid concentrations and compositions of 14 lipoprotein subclasses, measured by NMR
- Glycaemic response [ Time Frame: Up to 8 hours ]Plasma glucose concentration
- Insulinaemic response [ Time Frame: Up to 8 hours ]Plasma insulin concnetration
- Nitric oxide bioavailability [ Time Frame: Up to 8 hours ]Plasma nitric oxide species and NADPH oxidase activity
- Oxidative stress [ Time Frame: Up to 8 hours ]Plasma 8-isoprostane F2a
- Inflammatory response [ Time Frame: Up to 8 hours ]Plasma IL-6
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438084
|Department of Nutritional Sciences, Faculty of Life Sciences and Medicine, Kings College London|
|London, United Kingdom, SE1 9NH|
|King's College London|
|London, United Kingdom, SE1 9NH|