- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04156503
Pilot Study-Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy
A Pilot Study for the Quantitative Analysis of Positional Fatty Acids in Postprandial Chylomicron Triacylglycerol Using 13C NMR Spectroscopy
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Kajang, Selangor, Malaysia, 43000
- MalaysiaPOB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Test fat: Palm olein
One high fat muffin will be serves together with a glass of low fat milk shake.
|
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.
|
EXPERIMENTAL: Test fat: Lard
One high fat muffin will be serves together with a glass of low fat milk shake.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Up to hour 5
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Phooi Tee Voon, Ph.D, MPOB
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PD222/17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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