Ignite Creation Date:
2024-05-06 @ 10:12 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03191513
Status:
COMPLETED
Last Update Posted:
2020-10-26
First Post:
2017-05-23
Brief Title:
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
Sponsor:
Kings College London
Organization:
Kings College London
Study Overview
Official Title:
The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism
Status:
COMPLETED
Status Verified Date:
2017-05
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:
INTERMET
Brief Summary:
The purpose of this study is to investigate whether there are differences in postprandial metabolic indices following interesterified fats used commercially versus the corresponding un-interesterified blend
Detailed Description:
Aim The current study aims to investigate the acute effects of commercially relevant interesterified hardstock versus the corresponding un-interesterified blend on 8 h postprandial fat metabolism
Hypothesis Interesterification of a palm kernel and palm stearin fat blend to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride TAG but the same fatty acid composition will alter postprandial lipid metabolism
Subjects Participants will include 24 healthy male and female postmenopausal volunteers aged between the ages of 45 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 10 males and 10 females is required to detect a clinically relevant difference for males and females separately between means of 03 mmolL maximal difference in 8 h plasma TAG concentration standard deviation 033 mmolL significance level alpha of 005 and 80 power 12 males and 12 females will be recruited to allow for a 20 drop out rate
Expected valueThe study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia
Hypothesis Interesterification of a palm kernel and palm stearin fat blend to produce a fat with a higher proportion of palmitic acid in the middle position of the triglyceride TAG but the same fatty acid composition will alter postprandial lipid metabolism
Subjects Participants will include 24 healthy male and female postmenopausal volunteers aged between the ages of 45 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 10 males and 10 females is required to detect a clinically relevant difference for males and females separately between means of 03 mmolL maximal difference in 8 h plasma TAG concentration standard deviation 033 mmolL significance level alpha of 005 and 80 power 12 males and 12 females will be recruited to allow for a 20 drop out 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