Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:28 PM
Study NCT ID:
NCT01428960
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Metabolic Markers
Sponsor:
Malaysia Palm Oil Board
Organization:
Study Overview
Official Title:
Acute Effects of Sn-1 and Sn-3 Palmitic Acid-rich or Stearic Acid-rich Fats on Postprandial Lipemia, Haemostatic and Inflammatory Markers, Gut Hormone Concentrations, Satiety, and Insulinemic Response in Human Volunteers
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
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:
To determine the effect of degree of fat saturation on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety perceptions, and insulinemic responses in healthy adult subjects.
Study hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.
Study hypothesis: The degree of fat saturation does not affect postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, insulinemic or satiety responses in health adult subjects.
Detailed Description:
The experimental are comprise of 50g fat, 14g protein and 84g carbohydrate. Each of the test fat \[palm mid fraction (PMF), shea butter (SB) and high oleic sunflower oil (HOSF)\] will be compared which will be in a form of experimental meals (muffin).
33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is started mid-way of consuming the test meal.
At 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).
33 volunteers receives 3 experimental meals (muffins) in a random order, 2 week apart, over a 6-week period. They will be randomized, blinded and will undergo a 3x3 arms crossover. The first 15-ml ("0" min) fasting venous blood samples is obtained. Immediately thereafter, the subject consumes the test meal plus a glass of water within 15 minutes. The time sequence is started mid-way of consuming the test meal.
At 30 min, 60 min, 90, 120 min (2 hr), 150 min and 180 min (3 hr), 210 min, and 240 min (4 hr), 15-ml each of blood is collected (via a vascular catheter inserted earlier in the subjects hand/arm).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: