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Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

Primary Purpose

Endocrine System Diseases

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
ensure plus
standardized test meal
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endocrine System Diseases focused on measuring glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Hospital Basel, Phase 1 Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

satiation_obese weight

gastric emptying_obese weight

gastric emptying_normal weight

satiation_normal weight

hormone profiles_obese weight

hormone profiles_normal weight

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

gastrointestinal peptide secretion

Secondary Outcome Measures

gastric emptying
time needed to reach the level of satiation
total calorie intake

Full Information

First Posted
September 29, 2011
Last Updated
October 18, 2011
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01456572
Brief Title
Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
Official Title
Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocrine System Diseases
Keywords
glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
satiation_obese weight
Arm Type
Active Comparator
Arm Description
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.
Arm Title
gastric emptying_obese weight
Arm Type
Active Comparator
Arm Description
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.
Arm Title
gastric emptying_normal weight
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
satiation_normal weight
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
hormone profiles_obese weight
Arm Type
Active Comparator
Arm Description
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.
Arm Title
hormone profiles_normal weight
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
ensure plus
Intervention Description
17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
Intervention Type
Dietary Supplement
Intervention Name(s)
standardized test meal
Intervention Description
scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid
Primary Outcome Measure Information:
Title
gastrointestinal peptide secretion
Time Frame
2 hours blood sampling
Secondary Outcome Measure Information:
Title
gastric emptying
Time Frame
240 minutes end-expiratory breath sample collection
Title
time needed to reach the level of satiation
Time Frame
up to 30 min
Title
total calorie intake
Time Frame
up to 30 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Beglinger, MD
Organizational Affiliation
Phase 1 Research Unit, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Phase 1 Research Unit
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24582673
Citation
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.
Results Reference
derived

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Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

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