Clinical Trials Directory

Trials / Completed

CompletedNCT03191513

The Acute Effects of Interesterification of Commercially Used Fats on Postprandial Fat Metabolism

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

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 King's 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 0.3 mmol/L maximal difference in 8 h plasma TAG concentration (standard deviation 0.33 mmol/L, significance level (alpha) of 0.05 and 80% power). 12 males and 12 females will be recruited to allow for a 20% drop out rate. Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTInteresterified blend of palm kernal and plam stearin50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
DIETARY_SUPPLEMENTUn-interesterified blend of palm kernal and plam stearin50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
DIETARY_SUPPLEMENTRapeseed oil50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)

Timeline

Start date
2017-06-12
Primary completion
2018-05-15
Completion
2018-05-27
First posted
2017-06-19
Last updated
2020-10-26

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT03191513. Inclusion in this directory is not an endorsement.