Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01456572
First received: September 29, 2011
Last updated: October 18, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Endocrine System Diseases
Dietary Supplement: ensure plus
Dietary Supplement: standardized test meal
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • gastrointestinal peptide secretion [ Time Frame: 2 hours blood sampling ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gastric emptying [ Time Frame: 240 minutes end-expiratory breath sample collection ] [ Designated as safety issue: No ]
  • time needed to reach the level of satiation [ Time Frame: up to 30 min ] [ Designated as safety issue: No ]
  • total calorie intake [ Time Frame: up to 30 min ] [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: January 2007
Study Completion Date: July 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456572

Locations
Switzerland
University Hospital Basel, Phase 1 Research Unit
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Christoph Beglinger, MD Phase 1 Research Unit, University Hospital Basel
  More Information

No publications provided by University Hospital, Basel, Switzerland

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01456572     History of Changes
Other Study ID Numbers: EKBB 122/09
Study First Received: September 29, 2011
Last Updated: October 18, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
glucagon-like peptide-1
peptide tyrosine tyrosine
ghrelin
stomach
small intestine
gastric emptying

Additional relevant MeSH terms:
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014