Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01681459 |
| Other study ID # |
H-4-2011-060 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 5, 2012 |
| Last updated |
February 18, 2016 |
| Start date |
January 2012 |
| Est. completion date |
January 2015 |
Study information
| Verified date |
February 2016 |
| Source |
Hvidovre University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: The Regional Committee on Biomedical Research Ethics |
| Study type |
Observational
|
Clinical Trial Summary
In lean subjects, free fatty acid (FFA) promotes gut hormone release, delays gastric
emptying, and reduces appetite and energy intake more than an isocaloric load of
triglyceride (TG). In obesity, the gastrointestinal sensitivity to food components may be
reduced. In this study, the investigators compare the effects of the FFA oleic acid and the
TG olive oil on gut hormone secretion, gastric emptying, appetite sensation, and subsequent
energy intake in lean and severely obese subjects.
Description:
Nutritional lipid within the lumen of small intestine causes a range of physiological
responses that suppress appetite and reduce energy intake. Thus, intestinal fat promotes the
release of gastrointestinal hormones such as cholecystokinin (CCK), peptide-YY (PYY) and
glucagon-like peptide-1 (GLP-1) that modulate gastrointestinal motility and are important
for appetite regulation and food consumption.
The effect of ingested fat on gut hormone secretion is highly dependent on the lipolysis of
triglycerides (TGs) into free fatty acids (FFAs). It has been demonstrated that adding a
lipase inhibitor (tetrahydrolipstatin) to a pure fat meal accelerates gastric emptying and
reduces CCK release. Furthermore, administration of tetrahydrolipstatin with an
intraduodenal infusion of TG attenuates gastric relaxation and antro-pyloro-duodenal
motility and reduces the release of CCK, PYY, and GLP-1 compared to TG alone. Finally,
intragastric administration of FFA delays gastric emptying and augments the release of CCK
and PYY compared to an isocaloric administration of TG. Hence, the presence of FFAs more
than TGs within the small intestine seem to play a pivotal role in the regulation of
appetite and energy intake.
Whereas acute intake of FFA represents a potent stimulus for suppression of appetite and
energy intake, epidemiological evidence relates long-term high dietary fat intake with
obesity and it is known that obese individuals prefer food with high fat content. The
mechanisms behind this paradox remain unclear. However, sustained high fat-diet may change
gastromotor responses and gut hormonal release to a dietary load of lipids. Moreover
intraduodenal sensitivity to FFA (oleic acid) was recently reported to be reduced in obese
subjects. The reduced appetite and energy intake after FFAs compared to TGs may, therefore,
not apply to obese subjects.
The aims of this study are to evaluate gastric emptying, gut hormone secretion, appetite
sensation, and energy intake after isocaloric gastric administration of FFA (oleic acid) and
TG (olive oil) in lean and severely obese subjects.