Ileal BrakeNCT02500069
Location Specific Differences in Intestinal Brake Activation
A study testing Casein (in duodenum), Casein (in jejunum) and Casein (in ileum) in people with Ileal Brake and Satiety, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The appearance of intact macronutrients in the small intestine can result in the activation of an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileal Brake, Satiety, Overweight
- What is being tested?
- Casein (in duodenum), Casein (in jejunum) and Casein (in ileum)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2014to Mar 2015
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months (≤5% weight change)
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
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- Pregnancy, lactation
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Blood donation within 3 months before the study period
- Self-admitted HIV-positive state
- Weight <60kg
- Evidence of casein or sucrose hypersensitivity
- Participation in any other study in which radiation was used, within 12 months before the study period
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6003
About this study
Official title: The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release
The appearance of intact macronutrients in the small intestine can result in the activation of an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The researchers will investigate the effects of intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and glucose and insulin.
- Conditions
- Ileal Brake, Satiety, Overweight, Obesity, Overeating
- Being tested
- placebo, Casein (in duodenum), Casein (in jejunum), Casein (in ileum)
- Medical subject headings
- Overweight, Obesity, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
infusion of tap water in all regions (duodenum, jejunum and ileum)
Casein (in duodenum)Other
infusion of protein in duodenum
Casein (in jejunum)Other
infusion of protein in jejunum
Casein (in ileum)Other
infusion of protein in ileum
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Tap water infusion in all three locations (duodenum, jejunum and ileum) Receives: Other: placebo |
| Duodenum | Experimental | Infusion of casein in duodenum Receives: Other: Casein (in duodenum) |
| Jejunum | Experimental | Infusion of casein in jejunum Receives: Other: Casein (in jejunum) |
| Ileum | Experimental | Infusion of casein in ileum Receives: Other: Casein (in ileum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure ad libitum food intake at the end of the test day
Food intake measurement in kcal
Measured: 1 test day
Secondary outcomes (2)
VAS scores for hunger and satiety
Visual analogue scale for hunger and satiety in mm (0-100 mm scale)
Measured: 1 test day
GI peptides
Measurement of GI peptide release during protein infusion (CCK, GLP-1, PYY, insulin and glucose)
Measured: 1 test day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startMay 2014
- Primary completionDec 2014
- Study completionMar 2015
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 Ileal BrakeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A Masclee, Prof. dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500069
- Sponsor's protocol ID
- METC-14-3-006
- Status last verified
- Jul 2015
- First submitted
- 18 Mar 2014
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van Avesaat M, Ripken D, Hendriks HF, Masclee AA, Troost FJ. Small intestinal protein infusion in humans: evidence for a location-specific gradient in intestinal feedback on food intake and GI peptide release. Int J Obes (Lond). 2017 Feb;41(2):217-224. doi: 10.1038/ijo.2016.196. Epub 2016 Nov 4.
PubMed 27811949
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intestinal Brake Activation at Different Locations in the Gut on Food Intake and Hormone Release
- ClinicalTrials.gov ID
- NCT02500069
- Acronym / sponsor ID
- METC-14-3-006
- Conditions
- Ileal Brake, Satiety, Overweight, Obesity, Overeating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jul 2015 (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 appearance of intact macronutrients in the small intestine can result in the activation of an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The researchers will investigate the effects of intraduodenal, intrajejunal and intralileal infusion of casein (protein) on ad libitum food intake, satiation and in vivo release of the gut satiety peptides CCK, PYY and GLP-1 and glucose and insulin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboTap water infusion in all three locations (duodenum, jejunum and ileum) |
| Duodenum | Experimental | Other: Casein (in duodenum)Infusion of casein in duodenum |
| Jejunum | Experimental | Other: Casein (in jejunum)Infusion of casein in jejunum |
| Ileum | Experimental | Other: Casein (in ileum)Infusion of casein in ileum |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months (≤5% weight change)
Key exclusion criteria (14 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
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 |
|---|---|---|
| placeboinfusion of tap water in all regions (duodenum, jejunum and ileum) | Other | Placebo |
| Casein (in duodenum)infusion of protein in duodenum | Other | Duodenum |
| Casein (in jejunum)infusion of protein in jejunum | Other | Jejunum |
| Casein (in ileum)infusion of protein in ileum | Other | Ileum |
Primary outcome
To measure ad libitum food intake at the end of the test day
Time frame: 1 test day
Food intake measurement in kcal
2 secondary outcomes
VAS scores for hunger and satiety
Time frame: 1 test day
GI peptides
Time frame: 1 test day
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 16 Jul 2015.
- Derived from this study: PubMed 27811949van Avesaat M, Ripken D, Hendriks HF, Masclee AA, Troost FJ. Small intestinal protein infusion in humans: evidence for a location-specific gradient in intestinal feedback on food intake and GI peptide release. Int J Obes (Lond). 2017 Feb;41(2):217-224. doi: 10.1038/ijo.2016.196. Epub 2016 Nov 4.
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.
A Masclee, Prof. dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Casein (in duodenum), Casein (in jejunum) and Casein (in ileum) in people with Ileal Brake and Satiety, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 14 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 16 Jul 2015. 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 Netherlands. 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.
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?
To measure ad libitum food intake at the end of the test day (time frame: 1 test day). 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 NCT02500069, 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 16 Jul 2015.