Ignite Creation Date:
2024-05-06 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03438084
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2018-02-13
Brief Title:
The INTER-CARDIO Study The Impact of Commonly Consumed Fat on Cardiovascular Health a Randomised Controlled Trial
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
The INTER-CARDIO Study The Impact of Commonly Consumed Fat on Cardiovascular
Status:
COMPLETED
Status Verified Date:
2019-08
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:
INTER-CARDIO
Brief 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 Kings College London a sample size of 20 participants males and females separately will allow a 216 percentage unit difference in FMD to be detected 90 power 005 alpha SD 29 50 participants will be recruited allowing for a 20 dropout rate
Expected valueThe study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia
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 Kings College London a sample size of 20 participants males and females separately will allow a 216 percentage unit difference in FMD to be detected 90 power 005 alpha SD 29 50 participants will be recruited allowing for a 20 dropout rate
Expected valueThe study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia
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