NCT03438084

The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial

The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.

Detailed description

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.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Interesterified fat	50 g fat provided as commercially available interesterified fat.
DIETARY_SUPPLEMENT	Non- interesterified fat	50 g fat provided as commercially available non-interesterified fat.
DIETARY_SUPPLEMENT	Rapeseed oil	50 g fat provided as commercially available rapeseed oil.
DIETARY_SUPPLEMENT	Butter	50g fat provided as commercially available spreadable butter

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-10-01
• Completion: 2019-10-31
• First posted: 2018-02-19
• Last updated: 2020-01-27

Locations

2 sites across 1 country: United Kingdom