Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 2:53 PM
Ignite Modification Date: 2025-12-24 @ 2:53 PM
NCT ID: NCT01681459
Brief 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.
Detailed 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.
Study: NCT01681459
Study Brief:
Protocol Section: NCT01681459