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临床试验/NCT04156503
NCT04156503Unknown不适用

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

Malaysia Palm Oil Board1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2019年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
14
试验地点
1
主要终点
Triglycerides profile in chylomicron harvested

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 40 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Non muslim, aged between 25 - 40 yrs old.
  • •BMI between 20 - 27.5 kg/m
  • •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.

排除标准

  • •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.

研究组 & 干预措施

Test fat: Palm olein

Experimental

One high fat muffin will be serves together with a glass of low fat milk shake.

干预措施: Palm olein vs Lard (Other)

Test fat: Lard

Experimental

One high fat muffin will be serves together with a glass of low fat milk shake.

干预措施: Palm olein vs Lard (Other)

结局指标

主要结局

Triglycerides profile in chylomicron harvested

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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