Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT04156503
Status:
UNKNOWN
Last Update Posted:
2020-09-02
First Post:
2019-11-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study-Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy
Sponsor:
Malaysia Palm Oil Board
Organization:
Study Overview
Official Title:
A Pilot Study for the Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
13C NMR spectroscopy has been validated to be a rapid, direct and accurate quantitative method in determination of positional distribution of fatty acids in edible oils and fats, including the palm oil fractions (from soft olein to hard stearin). Nevertheless, there is paucity of literature describing its application in determining the positional fatty acid composition in blood triacylglycerols \& biological samples, despite its widely used application in edible oils and fats. The postprandial feeding intervention is aimed to harvest chylomicron rich in triglycerides (\~97% TAG) for NMR analysis.
Detailed Description:
A pilot postprandial study with double blind, 2x2 arms randomized crossover experimental design will be carried out. A total of 10 subjects (5 males, 5 females) will be recruited and divided into 2 groups. Each group will be assigned to one of the test fat and fed with test meal prepared with 50g of test fats. 10 mL of blood samples will be collected at time points 0 (baseline, before meal) and 3, 4 and 5h after finish the meal. There shall be a 2-weeks washout period between each test fat.
Test fats used for this study are palm olein, with predominantly oleic acid at sn-2 position of the triglyceride backbone (about 68%, Gunstone et al, 2007) and lard, with predominantly palmitic acid at sn-2 position (about 72%, Gunstone et al., 2007). A high fat muffin with 50g of test fat will be formulated using the above two test fats mentioned. On each study day, a high fat muffin will be served and a glass of skim milk will be provided for subjects to help the digestion of fats from the muffins.
Chylomicron will be harvested using the ultracentrifugation technique. Samples collected will be stored in -80°C prior to NMR analysis.
Test fats used for this study are palm olein, with predominantly oleic acid at sn-2 position of the triglyceride backbone (about 68%, Gunstone et al, 2007) and lard, with predominantly palmitic acid at sn-2 position (about 72%, Gunstone et al., 2007). A high fat muffin with 50g of test fat will be formulated using the above two test fats mentioned. On each study day, a high fat muffin will be served and a glass of skim milk will be provided for subjects to help the digestion of fats from the muffins.
Chylomicron will be harvested using the ultracentrifugation technique. Samples collected will be stored in -80°C prior to NMR analysis.
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?: