Effects of Lipids on Gastric Emptying, Satiety Hormones, and Appetite in Severe Overweight

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Hvidovre University Hospital
Sponsor:
Information provided by (Responsible Party):
Jan Lysgaard Madsen, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01681459
First received: September 5, 2012
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


Condition
Effects of Lipids on Gastric Emptying
Effects of Lipids on Satiety Hormones
Effects of Lipids on Appetite

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Lipids on Gastric Emptying, Satiety Hormones, and Appetite in Severe Overweight

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Biospecimen Retention:   Samples Without DNA

Plasma


Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

10 lean subjects and 10 severely obese subjects

Criteria

Inclusion Criteria:

  • Lean subjects: BMI 20-25
  • Severely obese subjects: BMI > 50

Exclusion Criteria:

-Gastrointestinal symptoms

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681459

Contacts
Contact: Jan Lysgård Madsen, MD, DMSc +45 38622188 jan.lysgaard.madsen@hvh.regionh.dk

Locations
Denmark
Hvidovre Hospital Recruiting
Hvidovre, Denmark, DK-2650
Contact: Jan L Madsen, MD, DMSc    +45 38622188    jan.lysgaard.madsen@hvh.regionh.dk   
Contact: Jesper Graff, MD, DMSc    +45 38622679    jesper.graff@hvh.regionh.dk   
Principal Investigator: Jan Lysgård Madsen, MD, DMsc         
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Jan Lysgaard Madsen, Chief Physician, MD, DMSci, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01681459     History of Changes
Other Study ID Numbers: H-4-2011-060
Study First Received: September 5, 2012
Last Updated: September 10, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
Free fatty acid
Triglyceride
Gastric emptying
Satiety hormones
Appetite
Severe obesity

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014