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Completed

NCT Number: NCT01456572

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Basel, Phase 1 Research Unit

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ensure plus

Dietary Supplement

17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL

standardized test meal

Dietary Supplement

scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid

Primary outcomes

  1. gastrointestinal peptide secretion

    Time frame: 2 hours blood sampling

Secondary outcomes

  1. gastric emptying

    Time frame: 240 minutes end-expiratory breath sample collection

  2. time needed to reach the level of satiation

    Time frame: up to 30 min

  3. total calorie intake

    Time frame: up to 30 min

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2011
Registry last updated
Oct 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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