Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

Phase 1

Completed

• Conditions: Endocrine System Diseases
• Interventions: Dietary Supplement: standardized test meal; Dietary Supplement: ensure plus

• Registration Number: NCT01456572
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2011-02
• Study Completion: 2011-07
• Study First Submitted: 2011-09-29
• Status Verified: 2011-10
• Study First Submitted QC: 2011-10-18
• Last Update Submitted: 2011-10-18
• Study First Posted: 2011-10-20
• Last Update Posted: 2011-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gastric emptying_normal weight	standardized test meal	Normal weight subjects will receive a standardized meal, consisting of two scrambled eggs (cooked with 10 g butter), placed on two slices of whole wheat bread and 200 mL of milk (in total: 468 kcal). The test meal will be labeled with 100 mg of 13C-octanoic acid for determination of gastric emptying.
satiation_normal weight	ensure plus	Normal weight subjects will receive a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate, 1 kcal/mL). Nutrient intake will be stopped when subjects had reached maximal or unbearable satiation; the time needed to reach the maximal level of satiation (tmax) and the quantity of volume drunk will be recorded and calorie intake calculated.
hormone profiles_obese weight	ensure plus	Obese subjects will receive 500 mL of a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate). At regular time intervals fasting and post-prandial blood samples will be collected.
satiation_obese weight	ensure plus	Obese subjects will receive a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate, 1 kcal/mL). Nutrient intake will be stopped when subjects had reached maximal or unbearable satiation; the time needed to reach the maximal level of satiation (tmax) and the quantity of volume drunk will be recorded and calorie intake calculated.
gastric emptying_obese weight	standardized test meal	Obese subjects will receive a standardized meal, consisting of two scrambled eggs (cooked with 10 g butter), placed on two slices of whole wheat bread and 200 mL of milk (in total: 468 kcal). The test meal will be labeled with 100 mg of 13C-octanoic acid for determination of gastric emptying.
hormone profiles_normal weight	ensure plus	Normal weight subjects will receive 500 mL of a complex nutrient drink (Ensure Plus; 17 % protein, 30 % fat and 53 % carbohydrate). At regular time intervals fasting and post-prandial blood samples will be collected.

Primary Outcome Measures

Name	Time	Method
gastrointestinal peptide secretion	2 hours blood sampling

Secondary Outcome Measures

Name	Time	Method
total calorie intake	up to 30 min
gastric emptying	240 minutes end-expiratory breath sample collection
time needed to reach the level of satiation	up to 30 min

Trial Locations

Locations (1)

University Hospital Basel, Phase 1 Research Unit; 🇨🇭 Basel, Basel-Stadt, Switzerland