Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People

October 18, 2011 updated by: University Hospital, Basel, Switzerland
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
gastrointestinal peptide secretion
Time Frame: 2 hours blood sampling
2 hours blood sampling

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
gastric emptying
Time Frame: 240 minutes end-expiratory breath sample collection
240 minutes end-expiratory breath sample collection
time needed to reach the level of satiation
Time Frame: up to 30 min
up to 30 min
total calorie intake
Time Frame: up to 30 min
up to 30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EKBB 122/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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