Endocrine System DiseasesPhase 1NCT01456572
Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
A Phase 1 study testing ensure plus and standardized test meal in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Endocrine System Diseases
- What is being tested?
- ensure plus and standardized test meal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Jul 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- age 18-45
Who cannot join
- smoking
- substance abuse
- regular intake of medication
- medical or psychiatric illness
- gastrointestinal disorders or food allergies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Phase 1 Research Unit
Basel, Canton of Basel-City, 4031
About this study
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.
Read the 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.
- Conditions
- Endocrine System Diseases
- Being tested
- ensure plus, standardized test meal
- Keywords
- glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ensure plusDietary supplement
17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
standardized test mealDietary supplement
scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid
| Study group | Role | What they receive |
|---|---|---|
| satiation_obese weight | Active comparator | 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. Receives: Dietary Supplement: ensure plus |
| gastric emptying_obese weight | Active comparator | 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. Receives: Dietary Supplement: standardized test meal |
| gastric emptying_normal weight | Placebo comparator | 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. Receives: Dietary Supplement: standardized test meal |
| satiation_normal weight | Placebo comparator | 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. Receives: Dietary Supplement: ensure plus |
| hormone profiles_obese weight | Active comparator | 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. Receives: Dietary Supplement: ensure plus |
| hormone profiles_normal weight | Placebo comparator | 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. Receives: Dietary Supplement: ensure plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal peptide secretion
Measured: 2 hours blood sampling
Secondary outcomes (3)
gastric emptying
Measured: 240 minutes end-expiratory breath sample collection
time needed to reach the level of satiation
Measured: up to 30 min
total calorie intake
Measured: up to 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2007
- Primary completionFeb 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endocrine System DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Beglinger, MD, Principal investigator, Phase 1 Research Unit, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456572
- Sponsor's protocol ID
- EKBB 122/09
- Status last verified
- Oct 2011
- First submitted
- 29 Sep 2011
- Last updated
- 20 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24582673
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
- ClinicalTrials.gov ID
- NCT01456572
- Acronym / sponsor ID
- EKBB 122/09
- Conditions
- Endocrine System Diseases
- Keywords
- glucagon-like peptide-1, peptide tyrosine tyrosine, ghrelin, stomach, small intestine, gastric emptying
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| satiation_obese weight | Active comparator | Dietary Supplement: ensure plusObese 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. |
| gastric emptying_obese weight | Active comparator | Dietary Supplement: standardized test mealObese 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. |
| gastric emptying_normal weight | Placebo comparator | Dietary Supplement: standardized test mealNormal 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. |
| satiation_normal weight | Placebo comparator | Dietary Supplement: ensure plusNormal 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. |
| hormone profiles_obese weight | Active comparator | Dietary Supplement: ensure plusObese 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. |
| hormone profiles_normal weight | Placebo comparator | Dietary Supplement: ensure plusNormal 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy subjects
- age 18-45
Key exclusion criteria (5 listed)
- smoking
- substance abuse
- regular intake of medication
- medical or psychiatric illness
- gastrointestinal disorders or food allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ensure plus17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL | Dietary supplement | hormone profiles_normal weight, hormone profiles_obese weight, satiation_normal weight, satiation_obese weight |
| standardized test mealscrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid | Dietary supplement | gastric emptying_normal weight, gastric emptying_obese weight |
Primary outcome
gastrointestinal peptide secretion
Time frame: 2 hours blood sampling
3 secondary outcomes
gastric emptying
Time frame: 240 minutes end-expiratory breath sample collection
time needed to reach the level of satiation
Time frame: up to 30 min
total calorie intake
Time frame: up to 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2011.
- Derived from this study: PubMed 24582673Meyer-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Beglinger, MD principal investigator
Phase 1 Research Unit, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ensure plus and standardized test meal in people with Endocrine System Diseases, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal peptide secretion (time frame: 2 hours blood sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01456572, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2011.