Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

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.

Study Overview

• Status: Completed
• Conditions: Endocrine System Diseases
• Intervention / Treatment: Dietary supplement: ensure plus; Dietary supplement: standardized test meal

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4031
      • University Hospital Basel, Phase 1 Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: satiation_obese weight; 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; 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
Active Comparator: gastric emptying_obese weight; 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; scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid
Placebo Comparator: gastric emptying_normal weight; 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; scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid
Placebo Comparator: satiation_normal weight; 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; 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
Active Comparator: hormone profiles_obese weight; 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; 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
Placebo Comparator: hormone profiles_normal weight; 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; 17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
gastrointestinal peptide secretion	2 hours blood sampling

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• Meyer-Gerspach AC, Wolnerhanssen B, Beglinger B, Nessenius F, Napitupulu M, Schulte FH, Steinert RE, Beglinger C. Gastric and intestinal satiation in obese and normal weight healthy people. Physiol Behav. 2014 Apr 22;129:265-71. doi: 10.1016/j.physbeh.2014.02.043. Epub 2014 Feb 28.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 29, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Estimate): October 20, 2011
• Last Update Submitted That Met QC Criteria: October 18, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: gastric emptying; ghrelin; stomach; glucagon-like peptide-1; small intestine; peptide tyrosine tyrosine
• Additional Relevant MeSH Terms: Endocrine System Diseases
• Other Study ID Numbers: EKBB 122/09