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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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date January 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- Lean subjects: BMI 20-25

- Severely obese subjects: BMI > 50

Exclusion Criteria:

-Gastrointestinal symptoms

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Hvidovre Hospital Hvidovre

Sponsors (1)

Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark,