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Completed

NCT Number: NCT04156503

Pilot Study-Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy

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.

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Key information

Conditions

Age range

25 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MalaysiaPOB

Kajang, Selangor, 43000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non muslim, aged between 25 - 40 yrs old.
  • BMI between 20 - 27.5 kg/m2.
  • Blood pressure with <130mmHg for systolic pressure and < 80 mmHg for diastolic pressure.
  • Blood glucose level in the range of 3.9 to 5.5 mmol/L.
  • Total cholesterol level < 6.0 mmol/L.
  • Triglycerides level < 2.3 mmol/L.
  • No use of tobacco and no consumption of alcohol.

Exclusion criteria

  • Suffer from chronic disease such as CVD, hypertension, diabetic, metabolic syndrome.
  • Consuming any medical prescriptions/ supplements.
  • Having blood clotting problem.
  • Women who are pregnant or lactating.
  • Hypertensive condition with systolic pressure >140mmHg and diastolic pressure > 90 mmHg.

Treatment and study plan

Palm olein vs Lard

Other

A 5-hour postprandial feeding intervention with 2-weeks washout in between. Blood samples will be collected at hour 0 (baseline) before test meal, and hour 3, 4 and 5 after consumption of test meal.

Primary outcomes

  1. Triglycerides profile in chylomicron harvested

    Time frame: Up to hour 5

    the positional composition of fatty acid in test fat that are retained upon absorption ( samples are pooled from 3, 4 &5 hour after test diet)

Sponsors and collaborators

Lead sponsor

Malaysia Palm Oil Board

Other Gov

Registry information

Official study title

A Pilot Study for the Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 7, 2019
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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