Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

Endocrine System Diseases Clinical Trial

Official title:

Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456572
• Other study ID #: EKBB 122/09
• Status: Completed
• Phase: Phase 1
• First received: September 29, 2011
• Last updated: October 18, 2011
• Start date: January 2007
• Est. completion date: July 2011

Study information

• Verified date: October 2011
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people.

Description:

Obesity has reached pandemic proportions, obesity-associated complications are extensive and the current treatment options are limited. These facts demonstrate the need for an improved understanding of the pathogenesis of obesity. The gastrointestinal tract plays a key element in the control of satiation; discrepancies exist, however, for the role of gastric and intestinal parameters in the control of satiation in relation to body mass. To achieve a comprehensive understanding for the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people the investigators will compare satiation parameters, gastric emptying and plasma glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY) and ghrelin levels between normal and obese healthy volunteers.

Time needed to reach the level of satiation and total calorie intake will be measured by a standardized nutrient drink test; gastric emptying of solids by a 13C-octanoic acid breath test; and plasma GLP-1, PYY and ghrelin levels will be measured after a standardized nutrient drink.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: July 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• healthy subjects

• age 18-45

Exclusion Criteria:

• smoking

• substance abuse

• regular intake of medication

• medical or psychiatric illness

• gastrointestinal disorders or food allergies

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Endocrine System Diseases

Intervention

Dietary Supplement:
• ensure plus
17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
• standardized test meal
scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Phase 1 Research Unit	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastrointestinal peptide secretion		2 hours blood sampling	No
Secondary	gastric emptying		240 minutes end-expiratory breath sample collection	No
Secondary	time needed to reach the level of satiation		up to 30 min	No
Secondary	total calorie intake		up to 30 min	No