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

September 29, 2011
October 18, 2011
January 2007
February 2011   (final data collection date for primary outcome measure)
gastrointestinal peptide secretion [ Time Frame: 2 hours blood sampling ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01456572 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Endocrine System Diseases
  • Dietary Supplement: ensure plus
    17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
  • Dietary Supplement: standardized test meal
    scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid
  • 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.
    Intervention: Dietary Supplement: ensure plus
  • 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.
    Intervention: Dietary Supplement: standardized test meal
  • 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.
    Intervention: Dietary Supplement: standardized test meal
  • 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.
    Intervention: Dietary Supplement: ensure plus
  • 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.
    Intervention: Dietary Supplement: ensure plus
  • 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.
    Intervention: Dietary Supplement: ensure plus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
July 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01456572
EKBB 122/09
No
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Christoph Beglinger, MD Phase 1 Research Unit, University Hospital Basel
University Hospital, Basel, Switzerland
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP