Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

Conditions
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Endocrine System Diseases

Intervention / Treatment
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* Dietary Supplement: ensure plus
* Dietary Supplement: standardized test meal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: satiation_obese weight<br>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. | Dietary Supplement: ensure plus<br>* 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL<br>|
| Active Comparator: gastric emptying_obese weight<br>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. | Dietary Supplement: standardized test meal<br>* scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid<br>|
| Placebo Comparator: gastric emptying_normal weight<br>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. | Dietary Supplement: standardized test meal<br>* scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid<br>|
| Placebo Comparator: satiation_normal weight<br>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. | Dietary Supplement: ensure plus<br>* 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL<br>|
| Active Comparator: hormone profiles_obese weight<br>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. | Dietary Supplement: ensure plus<br>* 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL<br>|
| Placebo Comparator: hormone profiles_normal weight<br>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. | Dietary Supplement: ensure plus<br>* 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastrointestinal peptide secretion |  | 2 hours blood sampling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric emptying |  | 240 minutes end-expiratory breath sample collection | 
| time needed to reach the level of satiation |  | up to 30 min | 
| total calorie intake |  | up to 30 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ghrelin, glucagon-like peptide-1, peptide tyrosine tyrosine, stomach, small intestine, gastric emptying